hvac
DESCRIPTION
teknologi sediaan sterilTRANSCRIPT
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 “
Heating, Ventilation and Air-
Conditioning (HVAC)
Introduction
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.
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
Faktor-faktor yang dapat mempengaruhi
kualitas produk farmasi
Starting materials
Personnel
Procedures
Validated processes
Equipment
Premises
Environment
Packing materials
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
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
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
Contamination
Contaminant
from
Environment
Operators
Contaminant
from
Equipment
Cross
Contamination
Product
from
Environment
Operators
Product
from
Equipment
Cross-Contamination
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
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
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)
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
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
HVAC
(2):
"At rest"
– Equipment may be operating, but
no operators present
– Mesin dalam keadaan operasi,
tanpa operator
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
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”
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
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)
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
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
Cleanroom Class
defined by
Critical Parameters
Air Handling
System Additional Measures
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
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
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
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
HVAC
Pola aliran udara
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.
Unidirectional/laminar
displacement of dirty air
Turbulent
dilution of dirty air
Airflow patterns
HVAC
Prefilter Airflow patterns
AHU
Main filter
Unidirectional Turbulent Turbulent
1 2 3
HVAC
Workbench (vertical) Cabin/booth Ceiling
Airflow patterns (4)
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).
HVAC
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
Komponen penyusun
HVAC sistem
+
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
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
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
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
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
Humidifier Silencer Heating and
cooling units
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
Primary panel filter
Secondary filter
HEPA or tertiary filter
HVAC
Positioning of filters (1)
Filter in terminal position AHU mounted final filter
Production Room
+
Production Room
HEPA Filter
HEPA Filter
HVAC
Prefilter
AHU
Main filter
1 2 3
Low level exhausts
Ceiling
exhausts
Positioning of filters (2)
HVAC
AHU Prefilter
Final filter
2 1
Positioning of filters (3)
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
Low induction
swirl diffusor
(preferred)
High induction
office type diffusor
(avoid)
HVAC
Regulation of room pressure – pressure differentials concept
Room pressure
gauges
Room pressure indication panel
HVAC
+
Production Room
Exhaust
air
Return air
(recirculated)
Fresh air
(make-up air) Supply
air
Air types
HVAC
Ventilation with recirculated air + make-up air
Central Air-Handling Unit
Return air
Exhaust Unit
HVAC