MAXHEAL PHARMACEUTICALS INDIA LTD CONTRACT MANUFACTURING MHRA-UK AND OTHER REGULATED MARKETS

Maxheal Laboratories Pvt. Ltd.

Welcome to thePresentation

on Maxheal Laboratories

Pvt. Ltd.

PROJECT INFORMATION1.1) Brief Description of Project

M/s. Maxheal Pharmaceuticals Pvt Ltd. envisages to build a Formulation manufacturing facility for Non Betalactum at Taluka Sachin, Dist. Surat for solid dosages in the form of Tablet and Capsule, Ointment in a self contained dedicated unit as per local FDA and international regulatory requirements like MHRA, USFDA, TGA, WHO GMP, etc.

PROJECT INFORMATION1.2) Site Selection Criteria

The proposed facility will be located in lush green and free from air pollution and having good quality of ground water. Also all surrounding units are non polluting and pharma friendly at 20 KM away from Surat at Gujarat (INDIA).

Project Location : At Taluka, Sachin, Dist. Surat, Gujarat, INDIA

PROJECT INFORMATION1.3) Land Area : Plot Area 13000 Sq. Mt.

Season Dry Bulb Relative Humidity

Summer 40.0˚C70%

Winter 28.0˚C50%

Monsoon 30.0˚C 85%

PRODUCTION CAPACITYNON BETALACTUM

Sr. No.

Particulars Capacity Per Shift

Per Month Per Year

01.0 Tablet (Uncoated / Coated)

2 Million 50 Mill. 600 Mill.

01.1 Capsule (Hard Gelatin)

0.8 Million 20.83 Mill. 250 Mill.

01.2 Ointment (30 gm) 20 Thousand Tubes.

0. 5 Mill. 6.0 Mill.

QUALIFICATION OF PRODUCTION MACHINE

PRODUCTION QUALIFICATION

4.1 Assumptions:

4.1.1 300 working days per annum.

4.1.2. Working hours 8 per shift/ day.

4.1.3. Production days 25 per month.

4.1.4 Production planning is based on per shift basis

4.3 Proposed Granulation:-

Granulation I :- (Batch Size 360 Kgs)

120 Kg Fluid Bed Processor. ( Gr-1)

Sifter 30 inches. , comill, Lifter.

3 lot from fabrication per shift total granules production for 360 Kg per shift.

600 & 1800Litres Blender with Bulk density of 0.6 In process Bins of 110 to 300 Kg for transfer to compression machine.

Output: 300 kg per day per shift x 21 days.

Granulation II :- (Batch Size 720 Kgs)

240 Kg Fluid Bed dryer.

240Kg Rapid Mixer and granulator.

Sifter 30 inches. , comill, Lifter.

3 lot from fabrication per shift total granules production for 720Kg per shift.

600 & 1800 Liters Blender with Bulk density of 0.6

In process Bins of 110 to 300 Kg for transfer to compression machine.

Output: 720 kg per day per shift x 21 days

Compression Area

4.4.1 Compression 2 Nos. Cubical Recommended.

Total Output 1080 Kg x 400mg Tablet / Shift ~ 2.0 Million /Shift.

Coating Area

Coating (2 Nos.) 0ne Pan 48” and one pan 60 inches

Capsule

Capsule filling room 2 Nos :- 2.0 Million / Day. Average Weight 250 mg, granulation required 250 kg per shift.

Recommended 1 Blender of 900 kg.

Capsule filling sealing Machine capacity 0.9 million / shift x 2 Machine.

Ointment Manufacturing Area:-

Manufacturing vessel 750Kg of Pharma tech Mumbai

Tube filling GAN + LS-120 of Wimco

Capacity 50000 Tubes per shift

Total Output 20000 Tube x 30 grams Tubes / Shift ~ 0.02 Million /Shift.

Packing area ( 6 Primary packing Line)

Total Packing requirement 3.0 Million tablet , capsule/ Shift.

Blister (240 Size) x 2 Lines.

ALU- ALU: 1 Line

Strip Packing: 1 Line

Total Packing = 25.0 million/shift

a) Tube Filling x 1 Lines.

Total Tube Packing = 0.050 million/shift

Formulation R&D :-

• We have Formulation R&D for Tablets ; Capsule and Ointments Section.

• Capacity is 5 Kg

• All machine are identical with Plant Machinery

Process Flow ChartTablet

DISPENSED RAW MATERIALS

MIXING

BLENDING

MILLING

DRYING

SIFTING

QC (HOLD)

COMPRESSION

QC HOLD

COATING

PRIMARY PACKING IN BLISTER/ STRIP/ BULK

INSPECTION

FINISHED GOOD STORE [QUARANTINE / APPROVED]

QC HOLD

SECONDARY PACKING

Process Flow ChartCapsule DISPENSED RAW

MATERIALS

TO -------DRYING (OPTIONAL)

SIFTING

MILLING

REJECT (HOLD)-------BLENDING

TO-----------QC (HOLD )

FILLING AND POLISHING

REJECT (HOLD )--------TO-----------QUARANTINE ( HOLD)

BLISTER STRIP BULK

FINISHED GOODS STORE [ Quarantine OR Approved ]

DISPENSED RAW MATERIALS

SIFTING OF DRUGS

OINTMENT BASE PREP DRUGS

MIXING & EMULSIFICATION

TUBE FILLING & CRIMPING

Quarantine ( Hold)

FINISHED GOODS STORE

TO QC FOR APPROVAL

Ointment

AREA QUALIFICATION

Area Statement

Plot Area : 13000 Sq. Mt.Production Block Ground Floor : 2625 Sq.Mt.Production Block Mazzanan Floor : 1207 Sq. Mt.Production area at First Floor : 2625 Sq.Mt. Production area at Second Floor : 1324 Sq.Mt. Total ( A) : 7781 Sq.MtADM+ QC/ R&D Area GF : 324.30 Sq MtADM+ QC/ R&D Area FF : 324.30 Sq MtADM+ QC/ R&D Area SF : 324.30 Sq Mt Total ( B) : 972.9 Sq.Mt Utility Block GF : 362.34 Sq Mt Utility Block FF : 362.34 Sq MtUtility Block SF : 67.86 Sq MtSecurity Cabin ( 1+2) : 60.00 Sq.Mt. Total ( C) : 852.54 Sq.Mt

Total Area : 9606.44 Sq Mtr (1,066,27 Sq. Foot )

MASTER SITE PLAN

MAIN PRODUCTION BLOCK

GROUND FLOOR PLANGROUND FLOOR PLAN

MAZZANINE FLOOR MAZZANINE FLOOR PLANPLAN

FIRST FLOOR PLANFIRST FLOOR PLAN

SERVICE FLOOR PLANSERVICE FLOOR PLAN

MACHINE LAYOUT PRODUCTION BLOCK

FIRST FLOOR PLAN (WITH MACHINE FIRST FLOOR PLAN (WITH MACHINE LAYOUT)LAYOUT)

MOVEMENTS PRODUCTION BLOCK

Movements Ground Floor

Movements First Floor

FINISHING DETAILSPRODUCTION BLOCK

35GROUND FLOOR GROUND FLOOR

FINISHINGFINISHING

36FIRST FLOOR FINISHINGFIRST FLOOR FINISHING

HVACPRODUCTION BLOCK

38GROUND FLOOR WITH AREA GROUND FLOOR WITH AREA

CLASSIFICATIONCLASSIFICATION

39FIRST FLOOR WITH AREA FIRST FLOOR WITH AREA

CLASSIFICATIONCLASSIFICATION

40GROUND FLOOR WITH PRESSURE GROUND FLOOR WITH PRESSURE

GRADIENTGRADIENT

41FIRST FLOOR WITH PRESSURE FIRST FLOOR WITH PRESSURE

GRADIENTGRADIENT

42GROUND FLOOR WITH AHU ZONINGGROUND FLOOR WITH AHU ZONING

43FIRST FLOOR WITH AHU ZONINGFIRST FLOOR WITH AHU ZONING

44MAZZANINE FLOOR WITH AHU MAZZANINE FLOOR WITH AHU

LOCATIONLOCATION

45SERVICE FLOOR WITH AHU LOCATIONSERVICE FLOOR WITH AHU LOCATION

ELECTRICALPRODUCTION BLOCK

47GROUND FLOOR LUX LEVELGROUND FLOOR LUX LEVEL

48FIRST FLOOR LUX LEVELFIRST FLOOR LUX LEVEL

49ELECTRICAL MASTER PLANELECTRICAL MASTER PLAN

SHEET -1SHEET -1

SHEET -2SHEET -2

ELECTRICAL MASTER PLANELECTRICAL MASTER PLAN

SHEET -3SHEET -3

SHEET -4SHEET -4

ELECTRICAL LOAD SUMMARYELECTRICAL LOAD SUMMARY

ADM/QC BLOCK

GROUND FLOOR PLAN GROUND FLOOR PLAN

(ADM OFFICE)(ADM OFFICE)

SECOND FLOOR PLAN SECOND FLOOR PLAN (QC/R&D)(QC/R&D)

UTILITY BLOCK

GROUND FLOOR PLANGROUND FLOOR PLAN

SECOND FLOOR PLANSECOND FLOOR PLAN

61WATER REPORTWATER REPORT

PURIFIED WATER GENERATION SYSTEMPURIFIED WATER GENERATION SYSTEM

PURIFIED WATER DISTRIBUTION PURIFIED WATER DISTRIBUTION SYSTEMSYSTEM

P&I DIAGRAM FOR STEAM P&I DIAGRAM FOR STEAM DISTRIBUTION DISTRIBUTION

P&I DIAGRAM FOR COMPRESSED AIR P&I DIAGRAM FOR COMPRESSED AIR

P&I DIAGRAM FOR STEAM P&I DIAGRAM FOR STEAM DISTRIBUTION DISTRIBUTION

Contact

• Maxheal Laboratories Pvt.Ltd

Head OfficeContact Person:Mr. Madan Sakhala, (MD)

• Address :103, Tulsi Niwas, Pushtikar Cooperative Society Ltd., Jogeshwari (W)Mumbai, Maharashtra - 400102, India

• Phone No:+ (91)-(22)-26786103/26786104Fax No:+ (91)-(22)-26786105

• E-mail :info@maxheal.in, madan@maxheal.in

Thank You

MAXHEAL PHARMACEUTICALS INDIA LTD CONTRACT MANUFACTURING MHRA-UK AND OTHER REGULATED MARKETS

production area

capsule shift

mt total area

packing area

production block ground

shift x

compression area

shift day

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