Designing of Aseptic Area and Clean Area Classification

A detailed overview of Designing of Aseptic Area and Clean Area Classification

1. UNIT III 4.1 Designing of Aseptic Area and Clean Area Classification Presented by: Mohammad Abuzar( M. Pharm ) Assistant Professor School of Pharmacy AIKTC, New Panvel .

2. CONTENTS 2

3. 3 INTRODUCTION Aseptic Area • A clean room is a room with environmental control of – Particulate contamination – Temperature and humidity – Constructed and used in such away as to minimize the introduction, generation and retention of the particles inside the room

4. 4 Design of Aseptic Area The design of aseptic area will be discussed under the following headings:  Size of aseptic room  Walls and ceilings  floors and drains  Doors, windows and fittings  Equipment  Pipelines  Cleansing  Disinfection and sterilization  Microbial checks

5. 5

6. 6 Size The proper size of an aseptic room depends on the maximum number of people which are going to use it The maintenance cost can be reduced if the aseptic room is a bit smaller in size The walls and the ceiling of the room should be of reasonable size so that it can be cleaned in routine without any difficulty Windows The windows in the room are a source of dust particles which may enter and contaminate the atmosphere In order to provide good light in the aseptic room, glass panes should be used Ventilation should be provided by laminar air flow system

7. 7 Doors T h e e n t r a n c e t o t h e ase p t i c r oo m s h o ul d b e t h r o ug h an a ir-l o ck w i th d o ubl e d o o r s a b o u t 1 m e t er a p a r t This is necessary to prevent a sudden inrush of air when the door is opened The outer door is opened only when it is confirmed that the inner door (which opens into the aseptic room)is closed. o r t hi s pur p o se a s m a l l w i nd o w i s n ee d ed i n t h e o u t e r d o o r The inner door is opened when the outer door is closed Ventilation It includes the removal of microorganisms, control of humidity and temperature and provision of fresh air The clean air free from microorganisms can be produced by mechanical filtration or electrostatic precipitation

8. 8 Surface Materials The floors, walls and the bench tops of an aseptic room must be smooth, resistant to chemicals and easily cleanable The floor of the aseptic room needs frequent washing to prevent the accumulation of dirt The floor should be built with Terrazzo (mixture of cement and crushed marble), Linoleum (heavy grade) and plastics The walls and ceiling should be provided with tiles or coated with hard glass paint or smooth plaster or covered with plastic laminated boards The working table tops should be made of stainless steel or plastic laminates so as to avoid accumulation of dust

9. 9 Electricity The electric supply is needed for lighting and functioning of equipment and machinery The switches and sockets should be flush fitting and have finger plates of plastic As far as possible, most of controls should be outside the room Gas supply is needed for burning of burners. Gas cocks may be on the walls or at the back of the bench. Vacuum arrangements for clarification and bacterial filtration. Disposal of waste :- In order to control the dust, such arrangement should be made that majority of the pipes and fitting get hidden in the walls of the room or these are properly covered

10. 10 Furniture Furniture such as working benches, chairs, trolleys and screens are used in an aseptic room The furniture should be such that there is the least number of undesirable dust retaining cavities HEPA Filters The key component is the High  fficiency Particulate Air (HEPA) filter that is used to trap particles that are 0.3 micron and larger in size All of the air delivered to a cleanroom passes through HEPA filters, and in some cases where stringent cleanliness performance is necessary, Ultra Low Particulate Air (ULPA) filters are used.

11. 11 Gowning in Clean Rooms Lab coats and hairnets Extensive as fully enveloped in multiple layered bunny suits with self-contained breathing apparatus Proper gowning order – Hair cover – Hood – Shoe covers – Coverall – Gloves – Face masks – Safety Glasses

12. 12 Cleaning and disinfection Cleaning and disinfection procedures are used for the removal of microbial and particulate contamination Cleaning agents are the alkaline detergents, non-ionic and ionic surfactants Different types of disinfectants should be employed in rotation to prevent the development of resistant strains of microorganisms Different concentration of quarternary ammonium compounds, sodium hypochloride , ethanol and formaldehyde solutions are used as disinfectants in cleaning area Cetrimide or chlorhexidine in 70% alcohol are suitable for use as sin disinfectants

13. 13 Air Supply The air supplied to a clean room must be filtered through high efficiency particulate air (HEPA) filters The HEPA filter must be positioned at the inlet of the clean room and the prefilter may be fitted upstream of the HEPA filters to prolong the life of final filter HEPA filters are used in the construction of vertical and horizontal laminar air flow bench The air filtered from the laminar air flow is claimed to be 99.97% free from the microbial contamination These filters are supported to provide class 100 air and they should be certified every 6 to 12 months Air quality is evaluated using settle plates, microbial air sampler or by particle counters

14. 14 Cleanroom Air Flow Principles C l ea n r o o m s m a in t a i n p a r t i c ul ate -fr e e a i r t hr o ug h t h e u se o f e i t h er HE P A o r U L P A fil t e r s e m p l oy in g l a m in a r o r turbulent air flow principles Laminar, or unidirectional, air flow systems direct filtered air downward in a constant stream Laminar air flow systems are typically employed across 100% of the ceiling to maintain constant, unidirectional flow L a m in ar f l o w c ri te r i a i s g e n e r a ll y sta t ed i n p o r ta bl e w o r k st a t i o n s ( h oo d s ), a n d i s m a nd a t ed i n IS O - 1 t h r o ug h IS O - 4 classified cleanrooms

15. 15 Laminar Flows Laminar air flows can maintain a working area devoid of contaminants. any medical and research laboratories require sterile working environments in order to carry out specialized wor k . 1. Vertical laminar air flow bench 2. Horizontal laminar air flow bench

16. 16

17. 17 Why Laminar Flow Cabinets? L a m in ar f l o w C a bin ets c r eate p a r t i c l e -f r ee working e n v ir o n m e n ts b y pr o j ect i n g a i r t hr o ug h a fi l t r at i o n s y st e m a n d ex h a u st in g i t a c r o s s a w o r k s urf ace i n a l a m in ar o r unidir ect i o n al a i r st r e a m They provide an excellent clean air environment for several laboratory requirements The process of laminar air flow can be described as airflow where an entire body of air flows with steady, uniform velocity L a m in ar f l o w C a bin ets w o r k b y t h e u se o f in-f l o w l a m in ar a i r dr a wn t h r o ug h o n e o r m o r e H E P A fil te r s , d e s ign ed to c r eate a p a r t i c l e -fr e e w o r k i n g e n v ir o n m e n t a n d pr o v i d e pr o du ct pr o t ect i o n Ai r i s taken t hr o ug h a fi l t r at i o n s y s t em a n d t h en ex h a u sted ac r o ss t h e w o r k s u r f ace as p a r t o f t h e l a m in ar fl o ws process. C o mm o nl y , t h e fil t r a t i o n s y st e m c o m pri s es o f a p r e -fil ter a n d a H E P A fi l ter

18. 18 Types of Laminar Flow Cabinets   Horizontal Laminar Flow Cabinets H o ri z o n tal La m in ar f l o w Ca bin ets r e ce i v e t h e i r n a m e du e t o t h e dir e c t i o n o f a i r fl o w w hi ch c o m es fro m a b o v e bu t t h en c h a ng es dir ect i o n a n d i s pr o ce s sed ac r o ss t h e w o r k i n a h o riz o n t al dir e c t i o n The constant flow of filtered air provides material and product protection. Vertical Laminar Flow Cabinets V e r t i cal L a m in ar f l o w C a bin ets fun ct i o n e qu a ll y we l l as h o ri z o n tal La m in ar l o w Ca bin ets w i th t h e l a m in a r a i r dir ec t ed v e r t i ca ll y d o w n wa rd s o n to t h e w o r k in g a r ea T h e a i r can l ea v e t h e w o r k in g a r ea v i a h o l es i n t h e b ase. Vertical flow cabinets can provide greater operator protection

19. 19 Cleanroom Classifications Cleanrooms are classified according to the number and size of particles permitted per volume of air La rg e nu m b e r s li k e "c l a s s 1 " o r "c l ass 1 " d e n o t e t h e n u m b er o f p a r t i c l es o f s iz e . 5 m m o r l a rg er p e r m i t t ed p er cubic foot of air Types of Clean Room Contaminants Air The production facility The production personnel Process water and chemicals Process gases Static electric charge

20. 20

21. 21

22. 22 Source of particulate contamination Examples The room itself dust and aerosols in the air The operator h a ir , sk i n fl a k es, b a c te ri a, a n d c l o t hin g fib e r s, fing er p r in ts The equipment fl ecks o f dr i ed pr o c ess in g c h e m i ca l s , du st, p a in t fl ak e s , fiber dust, wiper dust Glass or plastic dust fragments of glass or plastic from when they are cut Dirty solvents p a r t i c l es i n wa t e r , c l ea nin g s o l v e n ts, a n d t h e li k e Particulate Contamination

23. 23 Bacteria Cleanroom Contamination Bacteria are a natural part of the environment and may act as either a chemical or a particulate contaminant Clean environment minimizes the number of bacteria that are initially in the air Sneeze or a cough will generally put both bacteria and aerosol particles into the air Bac t e ri a a r e o n e v e r yo n e ’ s sk i n a n d sc r atc hin g ex p o s ed sk i n w il l pl ace b o th s k i n fl akes a n d b a c te ri a i n to t h e a i r Sources of Cleanroom Contamination The air in the facility The personnel in the facility (including things brought into the facility with them). The water used within the manufacturing process The chemicals and gases used in the process Static electric charge The production facility and equipment in the facility

24. 24 Prevention of Contamination Air La rg e fr act i o n o f t h e p a r t i c l es i n t h e a i r i n a c l ea n r oo m a r e r e m o v ed v i a H E P A ( h igh- e ffi c i e n cy p a r t i c l e at t e nu at i o n ) filters The Personnel Cover up as much as possible with low contamination clothing Water Contamination Issues The water used in many cleanroom manufacturing applications is treated to remove the following contaminants: dissolved minerals and salts, particulates, bacteria and organics

25. 25 Process Chemical Contamination To be delivered in clean, non-corrosive containers, transported ‘cleanly’ and not cross contaminated Equipment and Consumables used within the Cleanroom Must be compatible for used in a cleanroom Specialized cleanroom wipes, cleaning equipment and disinfectants will always be used.

26. 26 Summary • Design of clean room – building materials, walls, size, air handling systems, and HEPA filters • Laminar air flow cabinets – Horizontal and vertical; employ HPA filters to filter particulate contaminants from air to provide contamination free air for aseptic procedures • Sources of contamination – air, personnel, water, chemicals, etc. • Minimization of contamination – based on the source suitable contamination minimization techniques to be followed • Clean area classification – Class10, 100, 1000, 10000 and 100000

27. 27 W.B. Hugo and A.D. Russel: Pharmaceutical Microbiology, Blackwell Scientific publications, Oxford London. Prescott and Dunn., Industrial Microbiology, 4th edition, CBS Publishers & Distributors, Delhi. Pelczar , Chan Kreig , Microbiology, Tata McGraw Hill edn . Malcolm Harris, Balliere Tindall and Cox: Pharmaceutical Microbiology. Rose: Industrial Microbiology. Probisher , Hinsdill et al: Fundamentals of Microbiology, 9th ed. Japan Cooper and Gunn’s: Tutorial Pharmacy, CBS Publisher and Distribution. Peppler : Microbial Technology. I.P., B.P., U.S.P.- latest editions. Ananthnarayan : Text Book of Microbiology, Orient-Longman, Chennai Edward: Fundamentals of Microbiology. 12. N.K.Jain : Pharmaceutical Microbiology, Vallabh Prakashan , Delhi REFERENCES

28. 28