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1 Kualifikasi SISTEM untuk pabrik Farmasi Heating, Ventilation and Air Conditioning System (HVAC) Sistem Aliran Udara Water System Sistem Air (pengolahan dan distribusi) Compressed Air and other gases Sistem Udara bertekanan dan gas-gas lain “ Critical Plant System “
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Page 1: HVAC

1

Kualifikasi SISTEM untuk pabrik Farmasi

Heating, Ventilation and Air Conditioning System (HVAC)

– Sistem Aliran Udara

Water System – Sistem Air (pengolahan dan distribusi)

Compressed Air and other gases – Sistem Udara

bertekanan dan gas-gas lain

“ Critical Plant System “

Page 2: HVAC

Heating, Ventilation and Air-

Conditioning (HVAC)

Introduction

Page 3: HVAC

HVAC Tujuan

Untuk dapat memahami

Perlunya HVAC systems

peranan HVAC in dalam menjaga /protection: – Product

– Personnel

– Environment

peranan HVAC dalam „dust control‟

HVAC system design dan components.

Page 4: HVAC

HVAC

Ruang lingkup

HVAC systems can have an impact on product quality (HVAC

dapat berdampak pada kualitas produk)

It can provide comfortable conditions for operators (dapat

memberikan suasana yang nyaman pada operator)

The impact on premises and prevention of contamination and

cross-contamination to be considered at the design stage

(memberikan perlindungan terhadap Contamination dan cros

contamination )

Temperature, relative humidity control where appropriate

Page 5: HVAC

Faktor-faktor yang dapat mempengaruhi

kualitas produk farmasi

Starting materials

Personnel

Procedures

Validated processes

Equipment

Premises

Environment

Packing materials

Page 6: HVAC

Faktor – faktor yang harus diperhatiakn di area produksi yang dapat mempengaruhi kualitas produk :

1. Light ( penyinaran / penerangan area produksi )

2. Temperature ( suhu )

3. Relative humidity ( kelembaban )

4. Air movement ( pola aliran udara )

5. Microbial contamination ( kontaminasi mikroba )

6. Particulate contamination ( kontaminasi partikel asing )

Lingkungan yang tidak terkontrol akan memicu turunnya kualitas produk seperti produk yang terkontaminasi.

HVAC

Page 7: HVAC

Apakah yang dimaksud dengan kontaminasi ?

Adalah tercampurnya bahan kimia lain, mikro organisme, partikel

asing kedalam bahan baku, produk antara ataupun produk jadi

selama proses sampling, proses produksi, packing ataupun

repacking.

Apakah Cross-contamination /kontaminasi silang?

“Kontaminasi yang disebabkan tercampurnya bahan baku, produk antara ataupun produk jadi dengan bahan baku produk lain dan atau antar produk selama proses produksi.".

HVAC

Page 8: HVAC

Cross-contamination dapat disebabkan diantaranya oleh :

1. Jeleknya design, operasional ataupun pemeliharaan (maintenance) dari “ air-handling systems and dust extraction systems “

2. Tidak tersedianya prosedur (SOP) untuk alur personel, material dan peralatan (Inadequate procedures for, and movement of personnel, materials and equipment )

3. Insufficiently cleaned equipment ( peralatan yang tidak / kurang bersih.

HVAC

Page 9: HVAC

Contamination

Contaminant

from

Environment

Operators

Contaminant

from

Equipment

Cross

Contamination

Product

from

Environment

Operators

Product

from

Equipment

Cross-Contamination

HVAC

Page 10: HVAC

Cross-contamination can be minimized by, e.g.

1. Personnel procedures

2. Adequate premises

3. Use of closed production systems

4. Adequate, validated cleaning procedures

5. Appropriate levels of protection of product

6. Correct air pressure cascade

HVAC

Page 11: HVAC

HVAC

HVAC yang baik akan memberikan perlindungan terhadap:

Product protection : melindungi produk dari ;

– Contamination (kontaminasi)

– Cross-contamination (kontaminasi silang)

– Environmental conditions (pencemaran lingkungan)

Personnel protection

– Prevent contact ( melindungi kontak personel dengan produk)

– Comfort conditions ( membuat kondisi lebih nyaman)

Environment protection

Page 12: HVAC

HVAC

Protection: Product and personnel

Area dimana bahan baku dan produk disimpan harus berada pada ruang dengan klasifikasi bersih ( clean areas ).

Pencapaian klasifikasi “ clean area “ tergantung pada beberapa faktor diantaranya :

– Building finishes and structure (bangunan dan struktur bangunan )

– Air filtration (sistem penyaringan udara)

– Air change rate (pertukaran udara)

– Room pressure (tekanan udara dlm ruangan)

– Temperature (suhu)

– Relative humidity

– Material and personnel flow (alur barang dan manusia)

– Outside environment (lingkungan luar pabrik)

– Occupancy and type of product (jenis dan tipe dari produk)

Page 13: HVAC

HVAC

Air filtration and air change rate merupakan penentu untuk

tercapainya klasifikasi ruangan

Air change rate tergantung pada beberapa faktor diantaranya.

– Spesifikasi / klasifikasi ruangan

– Kualitas sistem filtrasi dari suplai udara

– Particulates generated

– Konfigurasi ruangan

– Infiltrasi partikel asing

– Suhu ruangan

– Tekanan udara ruanga

Air change rate normally varies between 6 – 20 air changes

per hour

Page 14: HVAC

HVAC

Pencapaian konsisi ruangan

sesuai dg spesifikasinya

dilakukan pada kondisi:

( 1 )

"As built"

– Bare room, without equipment or

personnel

– Ruangan kosong tanpa mesin

dan operator

Page 15: HVAC

HVAC

(2):

"At rest"

– Equipment may be operating, but

no operators present

– Mesin dalam keadaan operasi,

tanpa operator

Page 16: HVAC

HVAC

(3):

"In operation"

– Normal production process with

equipment and personnel,

– Proses produksi normal dengan

orang dan mesin.

– Clean up time validated –

normally in the order of 20

minutes

Page 17: HVAC

HVAC

Control of contaminants

External contaminants dapat dicegah dengan filtrasi yang

efektif.

Internal contaminants dicontrol melalui „flushing, or

displacement airflow‟

Sehingga cemaran partikel diudara dan sistem filtrasi

merupakan “critical factor”

Page 18: HVAC

Therapeutic risks

Man

ufa

ctu

ring

En

viro

nm

en

t

req

uire

me

nts

Cle

an

roo

m C

lass

A / B

Cle

an

roo

m C

lass

C

Cle

an

rm. C

lass D

Oth

ers

HVAC

Page 19: HVAC

HVAC

Level of protection and air cleanliness determined

according to (tingkat proteksi dan kebersihan

udara ditentukan berdasarkan):

Product to be manufactured (produk yg akan dibuat)

Process to be used (proses yg akan dilakukan)

Product susceptibility to degradation (kerentanan produk

terhadap degradasi)

Page 20: HVAC

Parameter yg berpengaruh pada kualitas udara :

Jumlah partikel diudara dan jumlah mikroorganisme diudara dan dipermukaan.

jumlah air changes pada tiap ruangan.

Air velocity dan airflow pattern

Filter (type, position)

Air pressure differentials antar ruangan.

Temperature, relative humidity (kelembaban relatif)

HVAC

Page 21: HVAC

Selain persyaratan tersebut, ada hal lain yang hrus diperhatikan :

appropriate gowning (type of clothing, proper changing

rooms)

validated sanitation

adequate transfer procedures for materials and personnel

HVAC

Page 22: HVAC

Cleanroom Class

defined by

Critical Parameters

Air Handling

System Additional Measures

HVAC

Page 23: HVAC

HVAC

Examples of levels of protection

Example of area Condition Level

Area with normal housekeeping, e.g.

warehouse

General Level 1

Area where steps are taken to protect

exposed material/product, e.g. dispensing

Protected Level 2

Area with defined, controlled, monitored

environmental conditions to prevent

contamination and degradation

Controlled Level 3

Page 24: HVAC

HVAC

Air Filtration

Penyaringan udara

Derajad penyaringan merupakan faktor yg penting untuk

mencegah kontaminasi.

Type filters yg akan dipakai tergantung pada kualitas udara

lingkungan,return air dan air change rates

Page 25: HVAC

HVAC

Levels of protection and recommended filtration

*Filter class should be referenced to the standard test method

Recommended filtration Level of

protection

Primary filters, e.g. EN779 G4* Level 1

Production area with 100% outside air: Primary plus

secondary filter (e.g. EN779 G4 plus F8 filters)

Level 2 and 3

Production area with recirculated plus ambient air with a risk

of cross-contamination: Primary plus secondary plus tertiary

filter (e.g. EN779 G4 plus F8 plus EN1822 H13 filters)

Level 2 and 3

Page 26: HVAC

HVAC

Contamination dapat dicegah dengan cara:

Materials for components and construction (pemilihan bahan dan konstruksi yg baik)

Design and appropriate access to dampers, filters and other components (desain dan akses aliran udara ke damper, filter dan komponen lainnya)

Personnel operations

Airflow direction (arah aliran udara yg baik)

Type of diffusers (non-induction type recommended)-tipe dari pendorong udara

Air exhaust (normally from a low level)sistem penghisap udara

Page 27: HVAC

HVAC

Pola aliran udara

Page 28: HVAC

HVAC

Airflow patterns

Filtered air entering a production room or covering a

process can be (udara tersaring yang masuk ke

ruang produksi ada dua tipe :

turbulent, or

unidirectional (laminar)

GMP aspect

economical aspect

Other technologies: barrier technology/isolator technology.

Page 29: HVAC

Unidirectional/laminar

displacement of dirty air

Turbulent

dilution of dirty air

Airflow patterns

HVAC

Page 30: HVAC

Prefilter Airflow patterns

AHU

Main filter

Unidirectional Turbulent Turbulent

1 2 3

HVAC

Page 31: HVAC

Workbench (vertical) Cabin/booth Ceiling

Airflow patterns (4)

HVAC

Page 32: HVAC

HVAC

Unidirectional airflow (UDAF):

Provided where needed over product or material to prevent

contamination, or to protect operator

UDAF in weighing areas

The aim is to provide dust containment (melindungi dari pengaruh debu)

Airflow velocity should not affect balance (kecepatan alir udara tidak boleh

mempengaruhi timbangan)

Position of material, balance, operator determined and validated – no

obstruction of airflow or risk (posisi dari material, timbangan dan operator

tidah berubah dan tervalidasi tidak menimbulkan gangguan atau resiko).

Page 33: HVAC

HVAC

Page 34: HVAC

HVAC

Page 35: HVAC

Pressure cascade solids

Protection from cross-contamination

Note : Direction of door opening relative to room pressure15 Pa15 Pa15 PaE30 PaPassage0 PaAirLock Room 3 Room 2 Room 115 PaAir LockAir Lock

Note : Direction of door opening relative to room pressure

15 Pa

15 Pa15 Pa

E30 Pa

Passage

0 Pa

Air

Lock

Room 3 Room 2 Room 1

15 Pa

Air LockAir Lock

HVAC

Page 36: HVAC

Komponen penyusun

HVAC sistem

Page 37: HVAC

+

Production Room

Exhaust air treatment

Central air handling unit

Terminal air treatment

at production room level

Fresh air treatment

(make-up air)

Sistem utama dari HVAC

Page 38: HVAC

Weather louvre

Silencer

Flow rate controller

Control damper

To prevent insects, leaves, dirt and rain from

entering ( mencegahmasuknya serangga, daun,

hujan dan cemaran lainnya dari luar )

To reduce noise caused by air circulation (

mengurangi kebisingan yang timbul karena

perputaran udara )

Automated adjustment of volume of air (night

and day, pressure control)pengendali

aliran/volume udara secara otomatis )

Fixed adjustment of volume of air

Components penyusun terdiri dari

HVAC

Page 39: HVAC

Heating unit

Cooling unit/ dehumidifier

Humidifier

Filters

Ducts

To heat the air to the proper temperature

(memanaskan udara sampai pada temperatur

yg dikehendaki )

To cool the air to the required temperature or

to remove moisture from the air (mendinginkan

dan mengurangi kelambaban udara

To bring the air to the proper humidity, if too

low ( menjaga kelembaban udara)

To eliminate particles of predetermined

dimensions and/or microorganisms (mencegah

masuknya partikel asing dan mikroorganisme)

To transport the air

Components (2)

HVAC

Page 40: HVAC

Filter Silencer

Terminal filter

Weather louvre Control damper

Fan Flow rate controller

Humidifier

Heating

coil

Cooling coil

with droplet

separator

Production Room

Skema komponen HVAC

+

Prefilter

Exhaust Air Grille

Heater

Secondary Filter

Recirculated air

HVAC

Page 41: HVAC

Control damper for airflow

De-humidification

Filter Pressure

Gauges

AHU with fan Variable

Speed Controller

Humid room air

Air heater

Regeneration air

Humid room air Adsorber wheel Dry air

Air-handling unit

HVAC

Page 42: HVAC

Humidifier Silencer Heating and

cooling units

HVAC

Page 43: HVAC

Filter classes Dust filters

Standard Aerosol

Fine Coarse ULPA HEPA

10 µ m > Dp > 1 µ m Dp > 10 µ m Dp < 1 µ m

F5 - F9 G1 - G4 U 14- 17 H 11 - 13

EN 1822 Standard EN 779 Standard

HVAC

Page 44: HVAC

Primary panel filter

Secondary filter

HEPA or tertiary filter

HVAC

Page 45: HVAC

Positioning of filters (1)

Filter in terminal position AHU mounted final filter

Production Room

+

Production Room

HEPA Filter

HEPA Filter

HVAC

Page 46: HVAC

Prefilter

AHU

Main filter

1 2 3

Low level exhausts

Ceiling

exhausts

Positioning of filters (2)

HVAC

Page 47: HVAC

AHU Prefilter

Final filter

2 1

Positioning of filters (3)

HVAC

Page 48: HVAC

Swirl Type air diffusors with

terminal filters 1 Filter

2 Tightening frame

3 Register outlet

4 Screw fixation for register

1

2

3

4

HVAC

Page 49: HVAC

Low induction

swirl diffusor

(preferred)

High induction

office type diffusor

(avoid)

HVAC

Page 50: HVAC

Regulation of room pressure – pressure differentials concept

Room pressure

gauges

Room pressure indication panel

HVAC

Page 51: HVAC

+

Production Room

Exhaust

air

Return air

(recirculated)

Fresh air

(make-up air) Supply

air

Air types

HVAC

Page 52: HVAC

Ventilation with recirculated air + make-up air

Central Air-Handling Unit

Return air

Exhaust Unit

HVAC