Aseptic area Unit 4 B pharm microbiology

Aseptic area
Sources of Contamination
Laminar flow equipment
HEPA FILTER

1. MIC ROBIOLOGY By ꜱᴀɴᴊɪᴠ ᴍᴀʟɪ

2. ASEPTIC AREA UNIT_4

3. Contents Designing of aseptic area Laminar flow equipments S tudy of different sources of contamination in an aseptic area

4. Designing of Aseptic area

5. What is ASPETIC? Aseptic means “free from living microorganisms" that can cause disease. The word septic means “infected” (the prefix a- in aseptic means “not”).

6. ASEPTIC AREA : It is a room within a clean area designed, constructed, serviced, and used for controlling and preventing microbial contamination of the product. In these areas it is mandatory to avoid provisions for dust to enter… Aseptic technique are used to prevent the acess of microbial & particulate contaminants into opthalmic and parental product…

7. Aspetic area are divided into 4 grades according to their operations Grade A - High Risk Operation Eg Filling and making Aseptic transfer Grade B - Background area of Grade _A Eg Preparation and Transport Grade C - Preparation of Sterile solution to be filtered Grade D - Cleaning of equipment Handling of components

8. Factor s for designing Aseptic area In aspe tic area all doors should be airlocked . Aspetic area should as far as possible from the normal areas to avoid unrelated persons. All surfaces,walls, roofs should be smooth, unbroken free from any cracks,to minimize the deposition of microbes.

9. Sliding doors are not allowed in asp etic area, Swing doors are allowed which is airlocked. It should open in the flow direction of air (+ve air pressure to -ve air pressure) There are 2 doors in aspetic area but both doors can't open at a same time. All utilities (pipes, ducts etc…)should be installed in such a way that they don't create recesses,unsealed opening.

10. Chan ging rooms should be designed air locked and physically separated to minimize Microbial contamination. A filtered air supply should be used to maintain a postive air pressure relative surrounding. HEPA - (High Efficiency Particulate Air)Filters are installed to filter the air and then which is supplied to aspetic rooms. It passes the air in aspetic area,which is free from microrganisms.

11. LAMINAR FLOW EQUIPMENT

12. L AMINAR FLOW EQUIPMENT Also Known as Lamina r air flow /Laminar flow cabinet /Tissue culture hood /clean benches. It is enclosed bench Designed to prevent contamination of microorganisms at time of biochemical testing, performing reaction,also use for sensitive materials.

13. It consists of filter pad,a fan(blower)&a HEPA filter and 1 laminar air flow bench. Air is passed though a HEPA filter which remove all airborne contamination to maintain sterile condition. It also consist switch for UV light, Visible light and for motor. It is made of SS with no gaps or joints.

14. Types of Laminar Fl ow cabinet Horizontal Laminar air flow Vertical laminar air flow

15. Working : Firstly on the UV lig ht about 30min to sterile the laminar flow… Then wipe the working surface with ethanol then use it. Then on the motor,the blower suck the air through the filter pad where dust is trapped. After that pre filter air has to pass the HEPA filter where microbes are removed. Sterile air flow into Working area.

16. Advantages This system is portable Helps to reduce turbulence Di sadvantages It is expensive UV rays are harmful to health

17. Sources of Contamination

18. So urces : Atmosphere Opera tor Raw material Equipment

19. Atmosphere Air is the major source of contamination as it contains dust particles, microbes,spores etc… It may reduced by chemical disinfection,UV light, filteration and gaseous agent and also by airlocked doors.

20. Oper ator The skin, hair and clothing of the operator are poten t source of microbial contamination. Operator do any manual contamination,may be due to lack of training or focus.

21. Ra w material It a cone for a high proportion of microbial contamination into pharmaceutical products (water is the major source) It may be due to improper sampling inadequate storage condition

22. Equipment The equipments and utensils used in a processing, holding, transferring and packaging are also common source of contamination of aseptic area. It is due to improper design materials lead to corrosion improper cleaning lack of sterilization etc…

23. THANK YOU ❤️ If you want to shine like a sun, first burn like a sun.