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AUTHORIZED TRANSLATION
ANNOUNCEMENT/GOVERNMENT REGULATION
TECHNICAL REQUIREMENTS OFMINERAL WATER INDUSTRY AND TRADE
(Decree of the Minister of Industry and Trade of
the Republic of Indonesia No. 167/MPP/Kep/5/1997
dated May 28, 1997)
THE MINISTER OF INDUSTRY AND TRADE OF
THE REPUBLIC OF INDONESIA,
Considering:
a. whereas to secure Mineral Water quality (AMDK) asprescr ibed in Na tional Quali ty Standard for Minera l Water (SNI-AMDK) and increase competitiveness as well as support fair
competition, it is necessary to stipulate Technical Requirements
of Mineral Water Industry and Trade.
b. whereas in this respect, it is considered necessary to issueDecree of the Minister of Industry and Trade.
In view of:
1. Law of the Republic of Indonesia Number 5 of 1984 (BN No. 4079pp . 5B-13B) regarding Industry (S tate Gazet te of 1984 No. 22,
Supplement to State Gazette No. 3274);2. Law of the Republic of Indonesia Number 23 of 1992 (BN No.
5321 pp. 5B-7B seq.) regarding Health (State Gazette of 1992 No.
100, Supplement to State Gazette No. 3495);
3. Law of the Republic of Indonesia Number 7 of 1996 (BN No. 5934pp . 20B-25B seq .) regarding Food (S tate Gazett e of 1996 No. 99 ,
Supplement to State Gazette No. 3656);
4. Government Regulation of the Republic of Indonesia Number 17of 1986 (BN No. 4338 pp. 12B-13B) regarding Authority to
Regulate, Promote and Development Industry (State Gazette of
1986 No. 23, Supplement to State Gazette No. 3330);
5. Government Regulation of the Republic of Indonesia Number 15of 1991 (BN No. 5089 pp. 3B-8B) regarding Indonesian National
Standard (State Gazette of 1991 No. 19, Supplement to State
Gazette No. 3434);
6. Government Regulation of the Republic of Indonesia Number 13of 1991 (BN No. 5713 pp. 18B-20B) regarding Industrial Permit
(State Gazette of 1995 No. 25, Supplement to State Gazette No.
3596);
7. Decree of the President of the Republic of Indonesia Number 12of 1991 (BN No. 5090 pp. 4B-7B) regarding Preparation,
Application and Supervision of Indonesian National Standard;
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8. Decree of the President of the Republic of Indonesia Number 2 of1996 (BN No. 5807 pp. 1B-2B) regarding Amendment to Decree
of the President of Number 15 of 1984 (BN No. 4064 pp. 9B-12B
seq.) regarding Organization Structure of Ministries as already
amended twenty five times recently by virtue of Decree of the
President No. 61 of 1995 (BN No. 5759 pp. 3B);9. Decree of the Minister of Industry No. 120/M/SK/10/1990 (BN
No. 5075 pp. 2B-3B) regard ing Appl icat ion of Indonesian
Industrial Standard (SII) and Compulsory SII Labelling on
Mineral Water (AMDK);
10. Decree of the Minister of Industry No. 250/M/SK/10/1994 (BNNo. 5710 pp. 1B-17B) regarding Technica l Guidelines on Draf ting
of Environmental Impacts Control in Industrial Sector;
11. Decree of the Minister of Industry No. 148/M/SK/7/1995 (BN No.5745 pp. 4B-7B) regarding Designation of Industrial Types and
Commodities Not Harming Environment nor Over-exploiting
Natural Resources;12. Decree of the Minister of Industry No. 150/M/SK/7/1995 (BN No.
5747 pp. 9B-12B seq.) regarding Procedure for Industrial and
Expansion Permits;
13 . Decree of the Minister of Industry and Trade Number29/MPP/SK/2/1996 jo. No. 92/MPP/Kep/4/1996 regarding
Organization and Work Procedure of the Ministry of Industry and
Trade;
14. Decree of the Minister of Industry and Trade No.108/MPP/Kep/5/1996 (BN No. 5880 pp. 11B-14B) regarding
Quality Standardization, Certification and Supervision within the
Ministry of Industry and Trade.
HAS DECIDED:
To stipulate:
DECREE OF THE MINISTER OF INDUSTRY AND TRADE
REGARDING TECHNICAL REQUIREMENTS OF MINERAL WATER
INDUSTRY AND TRADE.
CHAPTER I
GENERALArticle 1
In this Decree by:
1. Mineral Water (AMDK) we mean treated/processed, and safelypacked wa ter in order to be potable.
2. Raw water we mean raw material processed to Mineral Water(AMDK) originating from aquifer, natural spring on the surface
and/or Water Supply Company (PDAM) which takes untreated
water from springs.
3. Production process we mean raw water treatment in phases toproduce Mineral Water (AMDK).
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4. Mineral Water production machines/equipment we mean those touse in production process.
5. Mineral Water Laboratory Test Facility we mean any equipmentincluding reagents to assay quality in production process and
products thereof .
6. Mineral Water quality standard we mean quality standardstipulated by technical agency after approval from NationalStandardization Board (DSN).
7. Mark we mean mark in terms of drawing, name, word(s),character(s), number(s), color composition or combination thereof
with distinctive nature and used in goods or services trade.
8. Label we mean any indication or explanation on food in terms ofdrawing, or words or combination thereof, or other wise included
in food, or attached to or being a part of pack/container.
9. Pack/container we mean any products to contain or wrap food indirect contact with content, including lids thereof.
10. MD/ML Number we mean registration number and code issuedwith the Ministry of Health of the Republic of Indonesia for
local/imported food products.
11. Expiry date we mean end of period during which food quality isguaranteed provided it is stored as per instruction.
12. Production Code we mean production date and shift order in termsof numerals and or characters or otherwise indicating production
history.
13. Indonesian National Standard (SNI) we mean standard which isstipulated and applied by the Minister after approval from DSN
and nationally applicable in Indonesia.
14. SNI mark shall we mean be certification mark affixed on product,pack /con taine r or label indicating that the product compl ies with
SNI requirements.
15. Charge for making we mean agreement between producer andconsumer in which the producer shall produce and product with
brand as presc ribed by consumer.
16. Food grade substance we mean any substance which does not giverise any toxic, odor or taste, unabsorbtive, resistant against rust,
leaching and redesinfection.
17. Minister we mean be the Minist er of Industry and Trade.CHAPTER II
PRODUCTION PROCESS, PRODUCTION MACHINE/EQUIPMENT,
RAW WATER AND PLANT SITE
Article 2
(1) Mineral Water Company shall fulfill SNI and technicalrequirements as contained in Appendices I and II hereto.
(2 ) Each Mineral Water Company shall at least have mineral waterquality supervision laboratory with equipment as provided in
Appendix I hereto.
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(3 ) Quality control and test during production process shall be madeeach time to secure quality as required by the prevailing
requirements of National Industrial Standard of Mineral Water
(SNI AMDK).
(4 ) Product quality test shall be made at least semi-annually pursuantto the prevailing SNI AMDK (Mineral Water) and the resultthereof shall be reported to authorities issuing Industrial Operation
Permit or Certificate of Industrial Registration.
Article 3
Mineral Water Company shall have documents pertaining to
quality control and product quality test and they shall be kept for at
least for 2 (two) years.
Article 4
Each Mineral Water Company shall have machines/equipment
with installed capacity per shift of at least 10 (ten) million liters peryear.
Article 5
(1) Raw water for Mineral Water shall be clear, clean and chlorinefree.
(2 ) Raw water to process shall be taken from legal spring, it beingunderstood that the Mineral Water company shall be equipped with
Permit (SIP) and Water Recovery Permit (SIPA) issued by Mines
Office, and or certificate of cooperation or raw material acquisition
from local Water Supply Company.
(3 ) Sources of raw water from underground including springs shall besubject to continuous conservation and monitoring pursuant to the
prevailing legisla tion.
(4 ) Water from Local Water Supply Company (PDAM) which can beused as raw water shall originate from springs and be unprocessed.
(5 ) Raw water quality shall be periodically monitored by laboratorytest at least once quarterly.
(6 ) Sources of raw water shall be from safe location of at least 500 maway from source of contamination.
(7 ) Raw water transportation from source location to Mineral Waterplant sha ll comply wi th th e standard as re ferred to in Appendices Iand II thereto.
Article 6
Mineral Water Plant shall be situated at designated area pursuant
to spatial layout (RUTR) and/or close to terrestrial natural spring.
CHAPTER III
QUALITY
Article 7
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(1 ) The Mineral Water shall fulfill prevailing requirements of SNIAMDK (National Standard of Mineral Water).
(2 ) Any one alleging/finding Mineral Water of quality lower than SNIcan file his report/complaint to Regional Office of the Ministry of
Industry and Trade or Office of the Ministry of Industry and
Trade.(3 ) After receipt of report/complaint, the relevant Official shall make
an inspection.
(4 ) In case the inspection as referred to in paragraph (3) reveals anybreach he reof , the relevant competent Offic ial sha ll wi thin not
later than 7 (seven) working days issue suspension of production.
(5) The suspension can be revoked and the company can resumeproduction af te r ful fi llment of requi rements herein.
CHAPTER IV
CONTAINER
Article 8
(1) Container of Mineral Water made of Poly Etilene (PE),Poliprophilene (PP), Poly Etilene Tereftalate (PET) or Poly Vinyl
Chloride (PVC) shall be of food grade and disposable.
(2 ) Container of Mineral Water made of Poly Carbonate (PC) or glassshall fulfill hygienic requirements and be of food grade, washable
and non-disposable.
CHAPTER V
LABEL
Article 9
(1) Label shall comply with the prevailing legislation.(2 ) Each label shall at least include:
- Type of product: Mineral Water- Name and address of producer- Ne t volume in metric system- Brand/trademark- Production code- Registration Number from the Ministry of Health of the
Republic of Indonesia- Prevailing SNI AMDK number- Expiry date.
CHAPTER VI
MARKETING
Article 10
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(1 ) Domestic and imported Mineral Water which is distributed andmarketed shall:
- have label as referred to in Article 9.- have intact seal.- not be expired.- be contaminant free.(2 ) Imported Rural Water which is distributed or marketed shall meetSNI AMDK standard based on test result of accredited domestic
assay institution.
(3 ) Expense of test as referred to in paragraph (2) and sampling shallbe borne by the impor te r.
(4 ) No Mineral Water fai ling to fu lf il l requi rements hereof shall bedistributed.
(5 ) Distribution or marketing prohibition of Mineral Water shall bemade by the Director General of Domestic Trade by issuing
suspension of distribution.
(6 ) Product recall and destruction shall be made in not later than 2(two) weeks after receipt of suspension of distribution.
(7 ) No repackaging of opened fin ished con tainer of Mineral Wate r forredistribution shall be made.
(8 ) No Mineral Water company sha ll make charge of making wi thMineral Water producer and non Mineral Water producing
customers.
(9 ) No Mineral Water Test product shall be distr ibuted.CHAPTER VII
SUPERVISION
Article 11
Supervision of plant site, raw water, production process,
machine/equipment, product quality, and distributed product shall be
made at least semi annually or at anytime when needed.
Article 12
(1 ) The supervision as referred to in Article 11, shall be made by theDirectorate General of Agricultural and Forestry Produce Industry,
Regional Office/Local Office of the Ministry of Industry and
Trade and assisted by the relevant Government Agencies pursuantto their respective competence.
(2 ) Expenses of supervision as referred to in paragraph (1) shall becharged to budget of the Ministry of Industry and Trade.
(3 ) Finding of supervision as referred to in paragraph (1) andoccurring deviations shall be immediately reported to competent
authorities issuing Industrial Permit or Industrial Registration
Certificate for follow-up by making inspection as referred to in
article 7 paragraphs (4) and (5) hereof.
CHAPTER VIII
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SANCTIONS
Article 13
Any Mineral Water company/trader/importer failing to fulfill
requirements as referred to article 2 paragraphs (1) and (2), article 7
paragraph (1 ), art icl es 8 and 10 sha ll be sanc tioned by revocation ofIndustrial Permit and or Operation Permit or Importer Identification
Certificate.
Article 14
(1) Any Mineral Water company operating without fulfillingrequirements as referred to in Article 7 (1) shall be subjected to
criminal sanctions as referred to in Law Number 5 of 1984
regarding Industry, Law Number 23 of 1992 regarding Health and
Law Number 7 of 1996 regarding Food.
(2) Penal procedure as referred to in paragraph (1) shall be enforcedpursuant to the prevail ing legisl at ion.
CHAPTER IX
MISCELLANY
Article 15
Any Mineral Water companies operating and possessing
Industrial Registration Certificate but not yet fulfilling requirements as
referred to in Article 2 paragraphs (1) and (2), and other requirements
herein shall adjust themselves within 6 (six) months as of the issue
hereof.
Article 16
(1) No Mineral Water fa iling to fu lf il l technical requi rements asprov ided herein and preva iling quality standard of SNI AMDK
shall be produced.
(2 ) The suspension of production shall be issued by authoritiesissuing Industrial Permit or Industrial Registration Certificate.
(3 ) The cessation of production due to failure to fulfill technicalrequirements shall be made in not later than 2 (two) weeks as of
the issue of suspension of production.
(4 ) Cessation of production of Mineral Water failing to fulfill qualityrequirements in accordance with the prevailing SNI AMDK shallbe effec tive as of the issue of suspension .
Article 17
(1 ) Each Mineral Water company of AMDK shall report itscommencement of commercial production to the Authorities
Issuing Industrial Permit or Industrial Registration Certificate.
(2 ) In case of report of commencement of commercial production issubmitted to the Director General of Agricultural and Forestry
Produce Industry, the copy thereof shall be submitted to the Head
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of Regional Office and Local Office of the Ministry of Industry
and Trade.
(3 ) In case the report of commencement of commercial production issubmitted to the Head of the Regional Office of Ministry of
Industry and Trade the copy thereof shall be submitted to the
Director General of Agricultural and Forestry Produce Industryand Head of the Local Office/Agency of the Industry and Trade.
(4 ) In case report of commencement of commercial production shallbe submi tt ed to the Head of Of fi ce of the Mini st ry of Industry and
Trade the copy thereof shall be submitted to the Director General
of Agricultural and Forestry Produce Industry and Head of the
Local Office/Agency of the Ministry of Industry and Trade.
Article 18
Each Mineral Water product shall have trademark registered
with the Ministry of Justice and obtain Domestic Product (MD) or
Imported Product Number from the Ministry of Health.
Article 19
Implementation thereof shall be free of charge.
Article 20
Further necessary provisions shall be stipulated by Director
General of Agricultural and Forestry Produce Industry.
CHAPTER X
CLOSING
Article 21
By the effectiveness hereof, all regulations relating to Mineral
Water industry provided not in contravention hereof shall remain
effective until substituted.
Article 22
This Decree shall become effective as of the date of stipulation.
Stipulated in JakartaOn May 28, 1997
MINISTER OF INDUSTRY AND TRADE
signed
T. ARIWIBOWO
Translated from Bahasa Indonesia
Jakarta, August 14, 2003
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Authorized and Sworn Translator,
AUTHORIZED TRANSLATION
APPENDIX I:
GUIDELINE OF PRODUCED PROCESS MACHINE/
EQUIPMENT OF MINERAL WATER
Principally Mineral Water (AMDK) shall be processed through 3
phases namel y: fil te ring , di sinfection, and fi ll ing. Fi ltering is meant to
remove impurity and odor contained in the water. Disinfection is
intended to remove most of microbes and kill pathogenic bacteria in
water. Filling shall constitute the last step in terms of packaging
processed water.
1. RAW MATERIALGuarantee of raw water quality shall include:
a. Organoleptic examination covering odor, taste, color, andappearance.
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b. Raw water source shall be protected against E Colicontamination.
2. MACHINE/EQUIPMENTMachines/equipment to use produce Mineral Water shall take into
account at least 2 (two) aspects:2.1. Machine equipment Material
All machines/equipment in direct contact with raw water
shall be made of food grade materials.
2.1. Type of machine/equipmentMachine/equipment to be made available production process
shall be at least:
2.2.1. Tank for raw water.2.2.2. Machines/equipment of water treatment unit shall
consist of:
a. Sand filterb. Carbon filterc. Microfilterd. Ozone generatore. Ozone mixing tank
Note:
If additional ozonization is required, ultraviolet
light with wave length of 254 mm or 2537 A
and minimum intensity of 10,000 mw second per
cm 2 can be used.
2.2.3. Bottle washer2.2.4. Filler machine2.2.5. Capping machine.
3. LABORATORY FACILITYTo test Mineral Water the Company shall have quality control
laboratory. The laboratory equipment shall be able to analyze
minimum microbiological and physico-chemical parameters
required. The equipment shall among others be:
- autoclave- oven- incubator-
pH meter- conductivimeter- turbidimeter- microbiological test equipment- glass equipment such as petridish, erlenmeyer, etc.The company may possess sophisticated equipment for physico-
chemical test such as atomic absorption spectrophotometer for
metal contaminant test. However there is none, the test can be
made at accredit ed testing laboratory.
4. PRODUCTION PROCESS
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Production process of Mineral Water (AMDK) shall be as follows:
4.1. Raw water reservoir and requirements thereof.Raw water shall be collected in a reservoir. It shall be of
food grade and free from water contaminating materials. If
source of water is far from the plant, pipeline of food grade
or tanker can be used for its transportation. The tanker shallbe of food grade and easily cleaned and di sinfected.
Note:
Tankers, hoses, and joints for raw water transportation and
unloading shall be certified food grade. The tankers have to
be cleaned, san itized and inspected, int ernally and external ly
at least quarterly.
Tankers shall to be covered with lid with packaging and seal
at manhole.
Hoses and pumps to handle raw water shall be properlycovered, safely stored and protected against any possible
contamination.
Sampling at representative quantity shall be made at each
transportation of raw water for coliform bacteria
examination and Heterotrophic Plate Count (HPC). One
sample shall be taken from each tanker in 1 (one) week.
4.2. Filtering in phases consists of:4.2.1. Filter is made of sand or other effective filter of
the same function. Sand filter is meant to filter
coarse particles. The materials are Silica particles
(SO) of at least 95%. The mesh depends on water
clarity stated in NTU.
4.2.2. Carbon filterSide function of active carbon shall be absorbing
odor, taste, color, chlor residue and organic
materials.
Active carbon can originate from coal or coconut
shell.
Absortiveness against 1 2 shall be at least 75%
(SII-0258-88).4.2.3. Micro FilterMacro filter is fine mesh filter of not more than 10
(ten) micron.
4.3. DisinfectionDisinfection it intended to kill phatogenic bacteria. Its
process occurs in ozone mixing tank and during the
existence of ozone in the package. Ozone content in the
mixing tank shall be at least 2 ppn and ozone residue a while
after filling is between 0.0 and 0.4 ppm.
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Ozone content examination is periodicall y made and
documented in the company administration. Disinfection
besides us ing ozone, can be added by any othe r effect ive
means as Ultra Violet (UV) radiation.
4.4. Container Washing4.4.1. Non disposab le Containe rGlass bottle and PC (Poly Carbonate) bottles
which can be used repeatedly shall be washed and
sanitized in bottle washer. For bottle cleaning
various food grade detergent can be used at the
temperature of 60 - 85C, while for bottle
sanitation ozone water or other disinfectant of
food grade.
4.4.2. Disposable containerDisposable container is not necessarily washed
and/or rinsed, but if so, it should be madesanitarily.
4.4.3. InspectionPre and post washing inspection shall be made
visually and meticulously for appropriateness of
bo tt le use.
4.4.4. Container LidContainer lids shall be disinfected before use.
4.5. Filing, capping and packaging
4.5.1. Filling and capping of bottle or glasses.Filling and capping of bottles and glasses shall be
made mechanically by bottle or glass capping
machines the clean and sanitized filling room. The
room temperature shall not be more than 25C.
4.5.2. PackagingMineral Water Packaging shall be: cardbox, plastic shrink
or plastic crate.
4.6. Material4.6.1. Packaging Material and requirements thereof
Mineral Water container can be made of Poly
Ethylene (PE), Poly propylene (PP), PolyEthylene Tereftalate (PET), Poly Vynil Chloride
(PVC), Poly Carbonate (PC), or glass fulfilling
SNI 12-0037-1987.
4.6.2. RequirementsNo used containers made of PE , PP , PET or PVC
shall be used. While those made of PC or glass
shall be designed in such a way that they are
washable and reusable.
4.7. Quality Control and Test.
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Quality control and test for fulfillment of SNI AMDK shall
be made by means of taking 2 (two) samples upon bottling
in which 1 (one) sample is tested on the spot and the other
on the sixth day.
Parameters to test shall be as follows:
- Water condition: odor, taste, color- PH- Turbidity- Micro be contaminant; total plate quantity bacteria in
terms of coli, C. Perfringens, Salmonella.
APPENDIX II:
GOOD MINERAL WATER PRODUCTION/PRACTICE
( AMDK)
INTRODUCTIONPrincipally each factory including Mineral Water plant shall
adopt good production practice for good production. In addition, the
factory already adopting Good Production Practice shall be ready forinspection by the competent authorities.
In order to apply good production practice and understand
anything becoming the attention of inspection, we have to first
understand matters included in good production practice of Mineral
Water in order to be prepared. Further we have to be aware of our
preparedness.
The best way is to make internal audit.
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In the interest of internal audit, it is necessary to formulate a guideline. It
constitutes explanation of Good Mineral Water Production Practice.
Part 1: PLANT CONSTRUCTION AND DESIGN ITEMS 1 14Part 2: FACILITY AND SANITARY SUPERVISION: items 15 25
Part 3: SANITARY OPERATION: items 26 35Part 4: EQUIPMENT AND PROCEDURE: items 36 40
Part 5: PROCESS AND CONTROL: items 41 57Part 6: PERSONNEL: items 58 60.
Mode of factory inspection report with columns point and deficiency is
intended to give separate judgment of each factory. Score will be give to each
item in each part. For each item already having its point, the score, the higher the
point will be, but the highest is C, meaning, very significant.
This guideline refers to Plant Inspection Handbook of IBWA and
Bottled Water Plant Inspection, NSE.
PART I
FACTORY CONSTRUCTION AND DESIGN
Item 1. EQUIPMENT AND WASTE, REFUSE, LITTER SHALL
BE PROPERLY MANAGED.
It concerns factory exterior. Negative matters such as disorderly and
unsanitary equipment storage, dusty location, piled up waste every where, etc.
Caution:
- Equipment shall be orderly and sanitarily stored.- Avoid accumulation of dust at site. Avoid piling up of scrap and
waste at inappropriate places.
- Avoid small annual nests at building exterior.- Avoid disorderly piling around the building.- Do not store scrapped, unused and unprotected equipment outside,
since they way become nests of small annuals.
Item 2. CONTROLLING DUST AT STREET, YARD AND
PARKING LOT
Inspection will pay attention to situation at factorys yard and its impact on
factory sanitary condition, especially if containers and finished products
placed outside. Dust from unasphalted parking lot shall be kept minimum.
Recommendation: If necessary, water parking lot to minimize dust.
Item 3. ADEQUATE DRAINAGE SYSTEM
Outer part of the factory must be rather sloppy to allow proper drainage
and prevent from small animal nests.
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Item 4. ADEQUATE PLACE FOR EQUIPMENT AND MATERIAL
STORAGE, UNHINDERED AND ADEQUATELY SPECIOUS
ALLEYS AND WORK PLACE.
This item merely concerns space in the factory (as opposed to item 1
outside). The entire internal area shall be accessible for inspection andsupervision of cleanliness.
There must be a space between shelves and walls, and between lowest
shelves and floor. The entire area (production, warehouse, etc.) shall be
accessible for inspection and cleaning at any time. Employees can work as usual
during inspection, without any possibility of product contamination. Goods in
contact with products shall be separated from those not. If necessary those not in
contact with products can be placed on the floor but sanitarily.
Item 5. FLOOR WALL AND CEILINGCONSTRUCTION SHALL BE
GOOD AND CLEAN.
All cases on improper construction and poor cleanliness shall be recorded
in this item. Filling room walls shall be smooth and non absorbent for easy
cleaning. Bright color material is recommended. Walls and ceiling shall be intact.
Cracks shall be immediately, patched, polished and painted to recover smooth
and flat surface. Avoid any loose pipe unsulation in filling room. Floor, walls and
ceiling shall always be clean. Cleaning shall be made routinely and on schedule.
Item 6. FIXURES, SEWER AND PIPE SHALL BE LAID IN SUCH A
WAY THAT PREVENT CONTAMINATION DUE TO
LEAKAGE AND CONDENSATION
Avoid any leakage which may result in product contamination controlled
ambient temperature can reduce condensation rate in filling room.
Item 7. FILLING IS SEPARATED FROM ANY OTHER
OPERATIONAL ACTIVITIES OR STORAGE; WALL, AND
CEILING ARE INTACT. DOORS CLOSE AUTOMATICALLY,
SIZE OF CONVEYOR HOLE SHALL NOT EXCEED BOTTLESIZE
Filling Room (RP) shall be designed only for finished product filling.
No filling or packaging of other products shall be made in Filling Room (RP).
Use of other materials not hazardous to product cleanliness, such as: laboratory
cart for testing ozone shall be allowed. Walls and ceiling shall be intact. Access
to Filling Room can be through automatically closing door, but tightly closed,
both between two door panels and door and floor. Avoid use of curtain to access
filling room since it may create positive pressure. Conveyor hole is just enough
for bottle.
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Conveyor cover shall be available to protect open bottle month before
filling and capping. Plastic curtain and strips at conveyor hole can be used
provided that:
a) Airflow in the conveyor hole is positive.b) Conveyor cover is designed in such a way that it does not create repeat
contact between curtain and sanitized bottle lip.c) Curtain is cleaned and sanitized every day.
In case of using air curtain in conveyor hole, blower shall be installed
in Filling Room in order that clean air will flow through filter unit and around
bottles. Above the point where bottle lip will pass there shall be a small piece of
stainless steel of V shape. Air curtain housing, blower or fan blades shall be dust
free. Positive pressure in Filling Room is difficult to maintain if there is an
curtain. An curtain can not be used in access to Filling Room (RP) because it
does not work as properly as automatically closing door.
Positive pressure in Filling Room means higher air pressure insidethan outside the Filling Room. Positive pressure can be detected by putting a
piece of paper at the outlet of conveyor. If it is blown outward, the pressure is
positive. Filling Room (RP) shall be properly ventilated and incoming air should
be filtered and no ventilation hole shall open outward.
Ensure that all surfaces of equipment, wall, floor, etc., in Filling
Room (RP) are cleaned and sanitized daily. Make on the said cleanliness records,
only personnel doing assignment with special suits in Filling Space area.
No glass shall be used at door and window panels since they may
draw airborne dust and dirt.
Conveyor hole is just enough for bottle to pass. When being unused or
various bottle sizes are processed in the same filling room, the hole should be
able to be closed unless there is positive pressure system working continuously.
There must be filtered and UV radiated air supply.
Door should close automatically and window must remain closed.
Ventilation may not open outward the building. Design of Filling Room (RP)
must be in such a way that all surfaces and equipment therein can be cleaned and
sanitized daily. No employee unless so authorized with appropriate clothing shall
be in the Filling Room for test or necessary works (vide item 60).
Item 8. ILLUMINATION AT WORK PLACE, HAND WASH BASIN, OR
LOCKER ROOM, TOILET AND STORAGE ROOM OF AT
LEAST 50 FOOT CANDLE
Illumination in filling area, bottle washing area and anywhere in which
there is open product and surface in contact with product shall be at least 50 foot
candle. It is intended to give enough illumination to detect any physical
contamination. Illumination in other areas such as in handwashing basin,
equipment cleansing/repair are shall be at least 50 foot candle. Avoid delivery of
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goods in contact with product, such as gallon in trailer unless there is inadequate
illumination. Employees shall have good vision to detect product contamination.
Item 9. LAMP ABOVE PROCESSING AREA, SHALL BE OF SAFE
TYPE AND PROTECTED.
Lamps all over the factory shall be shatter resistant use of shatter resistant
and/or protected lamps in filling room is compulsory avoid glass fragment from
contaminating product.
Item 10. VENTILATION SHALL BE SUFFICIENT TO MINIMIZE
ODOR, GAS OR HAZARDOUS VAPOR, AND
CONDENSATE IN PROCESSING, FILLING, BOTTLE
WASHING, AND SANITATION ROOMS AND
VENTILATION SHALL BE CLEAN.
Filling room is the most important area. It must be adequately ventilatedto minimize possibly arising condensate at/or around filling machine. Condensate
entering bottles during filling process may cause product contamination. Bottle
washing and processing and other areas in the factory shall also be sufficiently
ventilated. It is important to routinely check and replace filter when necessary
and maintain the vent dust free, in order to keep ventilation clean.
Item 11. THERE SHALL BE SCREEN OR OTHER KINDS OF
PROTECTOR AGAINST BIRD, ANIMAL, INSECTS.
Open Exterior shall be protected by screen or automatic door.
Openings outward shall be blanked to prevent insects, birds and smallanimals from entering.
Doors connecting one room to another or to receive goods shall be always
tightly closed. If open for operation it must be ensured that product and container
contamination can be avoided and small animals can not enter the factory.
Item 12. Critical
PRODUCTION PROCESS USES CLOSED PRESSURIZED
PIPELINE: FREE OF OVER LEAKAGE AND
CONTAMINATION
Raw water supply must be in closed pipeline free of large leakage and in
sanitized condition to prevent contamination harming health. Large leakage is
leakage in which water comes out; small leakage is leakage in which water drops.
They will be recorded in item 21.
Pipeline must be pressurized, while storage tank hatch shall be tightly
closed.
Item 13. BOTTLE WASHING AND SANITATION IN CLOSED SPACE
AND PLACED IN SUCH A WAY TO MINIMIZE POST
SANITATION CONTAMINATION
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Bottle washer shall be installed in closed and protected area. Bottle
washer shall not be placed in filling room. Washed bottle conveyor shall be
covered to prevent post sanitation contamination.
Item 14. PROCESSING, WASHING AND STORAGE, INDIRECTLYCONNECTED TO HOUSEKEEPING UTENSILS ROOM.
Any activities not closely related to Mineral Water facility shall not be made
within the factory. For example: hotel laundry.
PART 2
SANITARY FACILITY AND SUPERVISION
Item 15. Critical
MINERAL WATER (AMDK) ORIGINATING FROM
LICENSED SPRINGS, PROPERLY SITUATED, SECURLYOPERATED, ACCESSIBLE, SAFE, AND SANITARY:
FULFILLING THE PREVAILING LEGISLATION
REGULATION AT ANY TIME.
Inspection includes visit to raw water source. Raw water source shall be
sanitarily constructed, operated, maintained and situated as well as comply with
the prevailing legislation. They shall all be properly documented. There must be
permits from local authorities for raw water sources operation for mineral water
production, site and ownership. Permits shall be maintained. Raw water sources
shall be indicated upon inspection. If possible inspector shall inspect each source.
It documents are no longer appropriate but sanitation is, it shall be recorded in
item 57. Unsanitary operated or managed sources will be recorded in this item.
Examples: debris around and at sources.
Item 16. WATER FOR OPERATION SHALL FULFILL THE SAME
REQUIREMENTS AS THOSE IN ITEM NO. 15.
Water for factory operation shall be water for washing, toilet,
maintenance, building cleaning, etc. In case of using water from Water Supply
Company (PAM), so water bill can be documented, other wise, all documents in
item 15 shall be maintained.
Item 17. Critical
RAW WATER IS ANALYZED SEMI ANNUALLY AGAINST
CHEMICAL AND PHYSICAL PARAMETERS;
RADIOLOGICAL PARAMETER EVERY FOUR YEARS
AND COLIFORMS QUALITY WEEKLY
This item only concerns raw water, and not finished product. Coliform
test for any raw water must be made at least weekly. Raw water is also tested at
least semi annually against chemical and physical parameters. Test results are
filed in the factory.
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Radiological test shall be made at least every 4 (four) years. Requirement
of each importing country may be different. In case of any test result from the
previous 6 (six) months, no critical difference will be recorded even though test
result of six (6) current months is not yet available. But in case of the absence of
test result of current and previous year, it will be recorded as critical.
Item 18. WATER SOURCE PERMIT FROM COMPETENT
AUTHORITIES
Factory shall be equiped with permit of raw water use for mineral water
production. In case of none, there must be another document overcoming such
deficiency. The documents shall be maintained for effectiveness. Expired
documents will be recorded as deficiency in item 57.
Item 19. PRESSURIZED AIR LEADING TO MINERAL WATER
(AMDK) OR SURFACE IN CONTACT WITH PRODUCT
SHALL BE FREE FROM OIL, DUST, RUST, EXCESSIVEHUMIDITY AND SHALL NOT AFFECT
BACTERIOLOGICAL QUALITY.
All air system openings shall be dust and dirt free. No spray of
pressurized air whether or not through filter shall be made, to surface directly in
contact with Mineral Water (AMDK) product. For better information on air
quality in the main areas such as filling room, it air bacteriological quality study
shall be made. Do not direct fan to clean bottles coming out from bottle washer
because fan blades are easily dusty.
Item 20. LOCKER AND DINING ROOM ARE SEPARATED FROM
OPERATION AREA AND STORAGE ROOM: FURNISHED
WITH AUTOMATIC DOOR; CLEAN AND SANITARY;
FURNISHED WITH GARBAGE CAN, WITHOUT ANY
PACKANGING; WRAPPING AND PROCESSING
MATERIALS.
Locker and dining rooms shall be separated from operation rooms such
as filling room and storage room, by automatic door and the area shall be free
from unnecessary goods. Dining room shall have closed garbage cans.
Item 21. SEWERAGE AND PIPELINE SHALL BE PROPERLY LAID
AND MAINTAINED
Deficiency of supervision of joint and maintenance of sewerage and
pipeline shall be recorded in this item. Minor deficiency is also recorded in this
item (vide item 12). This specific deficiency includes dirty air opening, sewer and
absence of back flow in water pipeline. area in which product can be
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contaminated due to or inadequate drainage system pipeline too
complicated to evaluate, will record in a report and must consult with or
construction expert to secure system integrity.
Item 22. SUFFICIENT FLOOR OF DRAINAGE TO REMOVE FLOOR
CLEANING WATER OR WATER SPILLED ON THEFLOOR DURING OPERATION
Floor in filling room or around bottle washer shall not be inundated.
There must be adequate drain personnel to prevent it.
Item 23. ADEQUATE TOILET FACILITY, WITH WASH BASIN,
SANITARY, AUTOMATIC DOOR NOT DIRECTLY
CONNECTED TO PROCESSING ROOM; WASH BASIN.
Hand washing warning must be attached above wash basin. Toilet facility
not processing room in which product and/or surface of product but 2sets of automatic door. Ventilation only is not acceptable, facility cleanliness
maintained. There must be vestibule and also window with blind shade or
exhaust fan.
Toilet is accessible. Running water works, soap and tissue or electric hand drier
shall be clean and bright.
Item 24. ADEQUATE AND ACCESSILE HAND WASHING FACILITY
AND ACCESSIBLE SHALL BE PROVIDED AT EACH
LOCATION EMPLOYEES HAVE TO WASH HANDS
SANITATION AND THEIR HANDS; WARM AND HOT
WATER CLEAN AND DRIER SHALL BE MADE
AVAILABLE
Wash basin in the room can be replaced by well maintained dip basin.
However, good and accessible wash basins mall production rooms are
recommended.
There shall be wash basin, soap and towel close to the filling room. If
necessary can be fitted besides wash basin.
Item 25. CLOSED GARBAGE CAN IS PROVIDED
Garbage cans in the locker and dining rooms shall be furnished with
lids. In room where product residue is placed no lid is required. All garbage
cans shall be in closed condition.
DIVISION 3
SANITARY OPERATING
Item 26. Critical
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ANY SURFACE IN CONTACT WITH MINERAL WATER
EQUIPMENT, PIPE, FIXTURES SHALL CLEANSED AND
SANITIZED DAILY.
Maintain complete and up to date records of cleansing and sanitation
procedures implemented throughout the plant as well as types of cleanser andsanitiser and producers thereof. They records shall be filed in MSDS (Material
Safety Data Sheet). All procedures shall apply and be implemented to any
surface in contact with products such as bars, fillers, lids and tank interior.
Item 27. SURFACE IN CONTACT MINERAL WATER SHALL BE
FREE FROM SCALE, OXIDATION AND OTHER RESIDUE.
ANY UNSANITARY CONDITION SHALL BE
IMMEDIATELY FIXED.
Any surface in contact with Mineral water shall not indicate any rust, oil,
dust, etc. and shall be maintained properly to minimize oxidation and scaling.Records on cleansing procedure shall be maintained.
Item 28. NON-DISPOSABLE CONTAINER, TOOLS, DISMANTLED
PIPE AND CLEANSED EQUIPMENT SHALL BE
TRANSPORTED AND STORED SANITARILY.
There shall be no item in contact with Mineral water stored on the floor or
ground inside or outside plant. It also applies to tankers hose (capped when not
in use) and transfer pipe, spare gasket, etc. Caution shall be made in their
transportation so as to secure their sanitation.
Item 29. BOTTLES, CAPS OR SEALS SHALL BE PURCHASED AND
KEPT IN THEIR SANITARY DEDICATED CONTAINERS,
IN CLEAN AND DRY PLACE, CHECKED BEFORE USE,
DISTRIBUTED AND USED SANITARILY, WASHED;
RINSED AND SANITIZED IF NECESSARY.
Inadequate handling and storage of disposable bottles shall be recorded in this
item. It usually occurs to bottles directly put on the floor (by floor we mean any
surface on which people can walk on), bottles put on the floor before
dismantling, improperly packed containers, disposable bottles put unsanitarily on
semi-trailer bed, etc. They shall be washed, rinsed and sanitized using mineralwater. No lid shall be left at hopper during down-time, but it protected against
contamination. Upon cleansing filling room and equipment, including hopper,
caps shall be kept away from hopper.
Item 30. SANITIZED OPEN BOTTLES SHALL BE PROTECTED AS
OF LEAVING WASHING PLANT THROUGH FILLING
PLANT.
Handling of non-disposable bottles is included in this item. Common error in
this case is absence of conveyor cover or inappropriate conveyor cover design
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thereby giving not enough protection. Conveyor cover shall be put in place from
washing through filling. This requirements shall also apply to manual operation.
Item 31. FILLING, LIDDING, CLOSING, SEALING AND PACKING
SHALL BE MADE SANITARILY.
The entire system should always be able to maintain product intactness.
Inspector shall monitor workers habit during filling process, closing and sealing.
If necessary, lidding can be made on conveyor between filling and closing to
avoid contramination. The inspector shall also monitor procedure for manual
closing whether or not it is made sanitarily.
Note:
- Product storage outside production room shall not constitute any violation ifmade sanitarily.
- Separate filling unit from other units is acceptable. However, its placementmay serve as a potential weakness. The inspector can not request for any
separate room for these units.- In case of single operator unit properly placed but without equal protection in
filling, closing and sealing units record will be made in this item.
If the design is satisfactory but not its placement, this inadequacy will be
recorded in item 7. If both placement design are inappropriate, record will be
made in items 7 and 31.
Item 32. CLEANSING OPERATION SHALL BE MADE IN SUCH A
AWAY THAT PREVENTS CONTAMINATION OF
SURFACE IN DIRECT CONTACT WITH PRODUCT.
All cleansing operations shall be made according to Good Manufacturing
Practice (GMP). Sanitizing agent concentration shall be as recommended. Record
on cleanser and its application shall be maintained.
Item 33. IT IS ONLY TOXIC MATERIALS WHICH ARE HIGHLY
NEEDED TO MAINTAIN EQUIPMENT OR TO USE INLABORATORIUM AND PROCESSING, THAT CAN BE
USED AND STORED AT THE FACTORY. THEY SHALL BE
CLEARLY LABELLED AND USED PROPERLY.
This item deals with toxic materials in the factory, not in the yard. If any, they
must be labelled and stored separately in designated area. Containers for toxic
materials shall be conspicuous and clear permanent labels. There shall be toxic
material use schedule.
Item 34. PESTICIDE USED ACCORDING TO INSTRUCTION AND
RESTRICTION STATED IN THE LABEL.
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Pesticide to use shall be that for food factory and its use shall be according to
instruction of producer. In case of using licensed pest control device, the
inspector shall discuss it with the management. Planning of pesticide use shall be
furnished with data on licensed officer target area, target species and
concentration of application. This information shall be filed in the factory.
Item 35. SURFACE OF EQUIPMENT NOT IN DIRECT CONTACT
WITH PRODUCT SHALL BE DUST AND DIRT FREE.
Any deficiency relating to cleanliness of surface not in contact with product
shall be recorded in this item. In case of a little accumulation of dust, nothing is
considered deficiency.
PART 4
EQUIPMENT AND PROCEDURE
Item 36. EQUIPMENT SHALL BE ADJUSTED TO USE, DESIGNED
AND MADE OF MATERIALS WHICH CAN BE CLEANED
AND MAINTAINED. DESIGN IS ADJUSTED TO PRODUCT
CONTAMINATION BY LUBRICANT AND METAL PIECES,
CONTAMINATED WATER. EQUIPMENT INCLUDING
RECERVOIR AND STORAGE TANKS, PIPES, JOINTS,
BOTTLE WASHER; FILLER, LOCKER, TANKERS, ETC.
- Specific deficiency relating to equipment under this item, Example:- Absence of hopper cover- Lubricant dripping from valve- Wood in filling room- Rust, debris, heavily damaged equiment- Pressure loss at copper pipe
Item 37. Critical
SURFACE IN DIRECT CONTACT WITH PRODUCT WATERSHALL BE OF FOOD GRADE, NON TOXIC AND NON
ABSORBENT; CLEANABLE, AND WELL SANITIZED.
Certification of supplier that material in direct contact with product is
non toxic and of food grade. It shall be filed for all materials such as pipe, valve,
packaging, fitting, water coller, etc. Packaging and locker are included in item
51.
If this certificates file is complete so the purpose of this requirement is
fulfilled. In complete documents must be completed. The documents must be
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renewed every two years, if not provided in each shipment. If product is
furnished with a certificate, the product fulfills requirements.
This item also pays attention to material intactness. The heavily damaged
packaging or cleaned spacers shall also be be recorded here.
Item 38. CLOSED STORAGE TANK TO AVOID OBJECT FROMOUTSIDE; AIR FILTER IS AVAILABLE AND THE FILTER
CAN BE CLEANED OR REPLACED EASILY.
Does Overflow function as ventilation? Ventilation shall have filter to
prevent insect and air borne dirt from entering empty tanks.
Item 39: Critical.
RAW WATER IS SEPARATED FROM WATER FOR
OPERATION TO PREVAIT PRODUCT CONTAMINATION;
IT CAN BE MADE BY SEPARATE PIPELINE OR
PREVENTING BACK FLOW.
If non product pipeline is not separated totally, cross connection shall be
controlled properly. Absence of control shall be recorded cross connection
control system shall be furnished with its scheme.
Item 40: RENOVATION OF SUPPLY EQUIPMENT; USE OF
APPROPRIATE COAT; WATER DISPENSING RESERVOIR
AND VALUES ARE PROPELY SANITIZED AND
PROTECTED BEFORE REUSE.
Deficiency of supply equipment is recorded to in this item. If includes, for
instance, absence of effective pest control program, absence of fumigation before
entering the cooling storage of cleaned bottle without cover, etc.
If cooler is coated, it shall use appropriate material. Renovation elsewhere is
not deficiency, except in case of indication of insect disturbance giving rise
problems to the factory.
PART 5
PROCESS AND CONTROLItem 41. Critical
WATER TREATMENT METHOD ASSISTS ATTAINING
GOAL; AVAILABILITY OF RECORDS OF TYPE AND
DATE OF TREATMENT; PHYSICAL INSPECTION OF
EQUIPMENT; NOTICED FEASIBILITY FOR USE AND
EFFECTIVENESS.
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If the highest disinfection standard is not adopted, it shall be recorded for
control. Check if there is any proper record of water treatment equipment
maintenance.
Item 42. Critical
EQUIPMENT TREATMENT. PROCESS AND USE OFMATERIAL TO PREVENT CONTAMINATION AND
PRODUCT IMPURITY.
Equipment and operation shall be designed in such a way that eliminates the
possibility of product contamination. No nominal water shall be carried, stored or
processed using non food grade equipment/means.
Item 43. WATERS SAMPLE IS TAKEN FROM PROCESSED WATER
BEFORE FILLING TO GUARANTEE UNIFORMITY AND
EFFECTIVENESS OF WATER, TREATMENT, ANALYSIS
METHOD SHALL BE FIRST APPROVED BY COMPETENTAUTHORITIES.
Test of product sample shall be made in compliance with the most recent best
method, whether sent to laboratory outhouse or inhouse. Vide IBWAs Plant
Technical Manual regarding Test Kis. All Q.C. monitoring methods shall be
accurate and reliable.
Example: ozonemeter shall be clean and its reagent is not yet expired.
Recommendation in Q.C. (Quality Control) program and IBWA:
- Ozone residue test at least three times (3x) (at the beginning and twice pershift), preferably hourly.
- Taste, pH, khlorine and conductivity frequency will be factory specific.There must be a record of effectiveness of processing, or performance and
condition of equipment. If using in-line monitor, it shall be calibrated.
Each outhouse test shall be made by accrediated laboratory. In-house
laboratory test by chemical and microbiological analysis shall be based on
Standard Method and documented.
Item 44. Critical
ALL UNSANITARY AND/OR DEFECTIVE CONTAINERS
WILL BE RECYCLED OR DISCARDED. NO NON
DISPOSABLE CONTAINERS SHALL BE CLEANSED,
SANITIZED, AND RE-EXAMINED BEFORE FILLING,
LAPPING AND SEALING.
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All non disposable bottles shall be cleansed and sanitized before filling.
In case of using non caustic cleansing agent, sanitation shall be performed. Non
disposable bottles can be cleansed by washing, rinsing, sanitizing, and rinsing by
ozonized water. The bottles shall be checked visually or electronically before
capping and filling. Unsanitary or difective bottles shall be physically declared
defective before disposal.
Absence of declaration of unusable of unsanitary or difective bottle may
result in critical record. If may lead to inadvertent filling and production of
contaminated product.
Item 45. CONTAINERS ARE RECHECKED FOR CAUSTIC RESIDUE
AND RECORDED.
Containers shall be rechecked for caustic residue or remaining non- caustic
material, depending on type of cleansing agent in use. Recording of remaining
material shall be available. (vide IBWA Plant Technical Manual).Item 46. MECHANICAL WASHER IS CHECKED AND RECORDED
FOR PHYSICAL MAINTENANCE, SUPERVISION, FOUND
CONDITION AND APPROPRIATENESS FOR USE.
This item deals with record relating to washer and its maintenance.
Matters such as glass screen cleaning, detergent and sanitation material
concentration checking, and other maintenance shall be recorded and evaluated.
Deficiency of external part of washer will be recorded in item 36.
Item 47. NON DISPOSABLE CRATE FOR TRANSPORTATION IS
MAINTAINED TO PREVAIT CONTAMINATION PRIMARY
CONTAINER OR PRODUCT.
Reusable used plastic crate shall be thoroughly cleansed before use.
Wooden crate can be used provided properly maintained and still in good
condition and no sanitation is required.
Item 48. SANITATION TREATMENT: RECORD CONCENTRATION
SANITATION MATERIAL AND LENGTH OF CONTACT
OF SANITATION MATERIAL WITH SANITIZED
SURFACE.
This item includes all records of sanitation treatment Use of check-off
system is possible if there is written Standard Operating Procedure specifying
what to do and how. Otherwise sanitation treatment shall be recorded in detail.
Item 49. EACH CONTAINER UNIT SHALL BE IDENTIFIED BY
PRODUCTION CODE, BATCH CODE, OF CONTINOUS
PRODUCTION AND PRODUCTION DAY.
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Coding can be made by giving notch on the label, by ink jet or otherwise
provided legible and in compliance with regulation and can be explained by the
company.
Item 50. THERE MUST BE RECORD OF TYPE OF PRODUCT,
VOLUME OF PRODUCT, PRODUCTION DATE, LOTCODE, AND DISTRIBUTION TO WHOLE SALERS AND
RETAIL OUTLETS.
Record of production, distribution and information of date code shall be
adequate to guarantee recall if necessary. Recall shall be planned in writing.
Name list is not adequate to be the procedure for valid recall.
Item 51. Critical
NON TOXIC CONTAINERS AND CAPS LOCKER; FOOD
GRADE STANDARD.
This item is basicly the same as item 37, but especially for containers and
caps. The file shall fulfill requirements if there is documentation available.
Item 52. FILLING, CAPPING AND SEALING WILL BE
MONITORED, FILLED CONTAINERS, ARE INSPECTED
VISUALY OR ELECTRONICALLY.
Bottling process must be monitored at any time. Limit of content shall be
checked by certain method. One of the methods is marking empty bottle sample
at the given limit then checked if the filter can fill it up to the such limit. It is
made several times during the shift, at least at each change of product or
container. It is also recommended to keep record of content limit check. If the
bottles are not capped or sealed properly, they are discarded or reprocessed.
Skilled manpower shall check the containers against foreign objects before
entering bottle washer and filling. Deficiencies relating to cleansing and
sanitation of non disposable container shall be recorded in item 44.
Item 53. Critical
COUNT TOTAL BACTERIA AND TOTAL FUNGUS BY
DIRECT INOCULATION METHOD DIRECTLY ONCONTAINER AND BOTTLE CAP BEFORE FILLING OF
EACH TYPE OF CONTAINER DAILY.
Count the total of bacteria and fungus on container and cap of each type of
container at quantity conforming to need of each plant. Coliform examination is
made quarterly and each sample shall be coliform free. There will be at least 2
samples for each type of product for Total Plate Count (TPC), Pseudomonas
Aerogenosa and fungus.
Item 54. Critical
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REPRESENTATIVE BACTERIOLOGICAL SAMPLING AT THE
BEGINNING AND END OF PRODUCTION OF EACH TYPE
OF PRODUCTS OF ONE DAY.
Each type of product shall be analyzed against Coliform each day and each
product shall be free from Colifrom. Plate Count test shall also be made daily atthe beginning and end of production of each type of product.
Note: for 5 gallons, fungus total checking is only made monthly.
Item 55. Critical
REPRESENT SAMPLES OF EACH TYPE OF PRODUCT
TAKING EVERY TWO MONTHS FOR FULL CHEMICAL
AND PHYSICAL ANALYSIS, RADIOLOGICAL
EXAMINATION ONCE IN 4 YEARS.
All analysis results shall be recorded and kept/filed.
Item 56. MAKING RECORD OF DATE OF SAMPING, TYPE OF
PRODUCT, PRODUCTION CODE, AND ANALYSIS
RESULTS FINDINGS.
All records of items 54 and 55 shall contain clear information of sampling of
each type of product, but understandable and identifiable to identity the product
itself. Production code should facilitate distribution tracing.
Item 57. RECORDS ARE KEPT FOR 2 YEARS CERTIFICATE
OR APPROVAL FROM COMPETENT AUTHORITIES
RESOURCES AND PRODUCT AND WATER SUPPLY FOR
OPERATION ARE FILED.
All records shall be kept for at least 2 years. Certificate of the factorys
products shall also be kept for 2 years. Each expired permit shall be recorded in
this item.
SECTION 6
PERSONNEL
Item 58. FACTORY AND PERSONAL SANITATION UNDER
SUPERVISION OF APPOINTED OFFICIAL.
Official appointed and responsible for factory operation or his
successor/assignee shall be available during a shift and inspection. Whether or
not he is available will be recorded upon inspection.
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Item 59. Critical
ANY PERSONNEL WHATEVER THE POSITION WHO
SUFFERS FROM COMMUNICABLE DISEASE SHALL NOT
WORK IN CASE OF ANY POSSIBILITY OF
CONTAMINATION OF PRODUCT OR COMMUNICATIONTO OTHERS.
The manager shall be responsible for prohibiting any employee who suffers
from communicable disease to enter any area possibility of product
contamination. The area includes filling room, testing and any equipment in
contact with the product. The manager shall make a wise decision on employee
suffering from bad flu; infected wound, sore (fester) etc. Hygiene program at
work place will very help making employees aware of hygienic practice.
Item 60. PRODUCTION PERSONNEL IN DAILY PRACTICE:
WEARING CLEAN CLOTHES; DEMONSTRATINGHYGIENE/CLEANLINESS; WASHING HANDS PROPERLY;
NO WRIST ACCESSORIES; WEARING EFFECTIVE HAIR
NET/COVER; NOT USING TOBACCO OF ANY FORM; NOT
EATING AT WORK PLACE.
No smoking, eating or drinking shall be allowed at retricted places. Automatic
dispensing machine can be placed outside dining room, provided the food is
consumed in the dining room. Hair cover/net must be worn in the entire
processing area especially filling room. Any employee noticed not washing
his/her hands properly will be recorded this item.
Special apparel shall be worn in filling room. It will be living close to the
filling room.
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APPENDIX II.
MODEL OF FACTORY INSPECTION REPORT
Company areaCompany Brand Factory Address Company Address
Date of Inspection Total Control recorded Sanitary Condition
Company Permit No. Name of Factory
Manager
Address:
Phone :
Company Permit No. Name of Factory
Manager
Address:
Phone :
Company Permit No. Name of Factory
Manager
Address:
Phone :
Inspection result
discussed with:
Name of Inspector:
Instruction: Record deficiency. In case of any doubtfill item write TDT.
TDT = Not acceptable
C = Acceptable= Note
= Not observed
(Max TDT) (K)
Score= ----------------- x 100% - 1 NPS (Sanitary fulfillment
(Max TDT) Score)
Note :
..
Max = Total point
X = Deficency
Number Po int Deficiency Factory Cons truction and Design
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necessary
30 5 Open bottle already sanitized shall be
protected since coming ou t from washing
until filling
31 5 Filling, capping sealing and packaging
shall be sanitarily made32 5 Cleaning shall be made in such a way that
prevent s the contaminatio n to sur face in
direct contact with product
33 4 It is only toxic materials necessary to
protect the sani tary cond ition of facto ry
and equipment or for use laboratory and
processing, tha t can be used and stored in
the factory. They are labelled and used
proper ly
34 5 Pesticide shall be used as instructed
according to restriction contained in the
label
35 5 Equipment surface not in direct contact
with product shall be free from dust and
dirt accumulation
36 5 Equipment is adjusted to utilization,
designed and made from the materials
which can cleaned and maintained
properly. Design is adjus ted to occur rence
of product contamination by lubricant and
metal particles, contaminated water. Theequipment includes reservoir and storage
tanks, joint, bottle washer, filler, cap
tankers etc.
37 C Surface in direct contact with water
produc t sha ll of food grade, non-tox ic and
not absorbent, can cleaned and sanitized
proper ly
38 5 Storage tank is closed to prevent foreign
objects from outside, furnished with air
filter and the filter can be cleaned and
replaced easily39 C Raw water is separated from water for
operation to prevent contamination of
produc t, it can be made by separate
pipeline or black flow prevent ion
40 5 Renewal of supply equipment, use of
appropriate coating water dispensing
reservoir and values are sanitized and
proper ly protected be fore reuse
41 C Water treatment method helps attaining
goal, record type and date of treatment,
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inspection of equipment physicals
condition. Condition found, feasibility for
use and effectiveness found
42 C Treatment process of equipment and use of
material to prevent product contamination
and impurities43 5 Water sample after and before filling to
guarantee uniformity and effectiveness of
water treatment. Analysis method shall be
subject to approval of competent
authorities.
44 C Unsanitary and defective containers shall
be recycled or declare d un us ab le and
discarded. Non disposable containers shall
be cl eaned, sani ti zed and inspected be fore
filling, capping and sealing
45 4 Containers are reinspected for causticresidue and recorded
46 4 Mechanical washer shall be inspected and
recorded as to physical maintenance
supervision, condition found feasibility for
use
47 4 Non disposable crate for transportat ion
shall be maintained to guarantee non
contamination to primary container or
produc t
48 5 Sanitation treatment, record concentrat ionof sanitation material and length of time of
sanitation material in contact with sanitized
surface
50 4 Record of type of product, production
volume, production date lot code in use and
distribution to wholesalers and retail
outlets
51 C Containers and bottle caps are non-toxic
pursuant to food grade standard
52 4 Filling, capping and sealing shall be
monitored, filled containers are inspectedvisually or electronically
53 C Count total bacteri a and fungus by direct
inoculation at container and cap before
filling of each type of container daily
54 C Representa tive bacteriological sampling at
the beginning and end of production of
each type of product in one day
55 C Taking representa tive sample twice a
month from each type of product for full
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chemical and physical analysis.
Radiological inspection is made every four
years.
56 3 Record date of sampling, type of product,
produc tion code and analysis resul t
58 5 Overall factory and sanitation undersupervision of competent authorities
59 C Personnel suffering from communicable
diseases shall not work if giving rise to
possible con tamina tion to produc t or
disease communication to other person
60 6 Personnel in production shall wear clean
clothes, demonstrate cleanliness was hands
properly, no t us ing wr ist accessories,
wearing effective hair cover/net not using
tobacco in any form, not eating at work
pl ace
Translated from Bahasa Indonesia
Jakarta, August 14, 2003
Authorized and Sworn Translator,