Designing of aseptic area - Microbiology

B. Pharmacy 3rd Semester

Microbiology,

Unit-4th 

Syllabus ( Acc. to PCI ) 

Designing of Aseptic Area, Laminar Flow Equipment, Study of difference of contamination in an aseptic area and method of prevention, Clean area classification.
Principles and method of different microbiological Assay, Method for standardization of Antibiotics, Vitamins and Amino acids. Assesment of a new antibiotics.

⬧  Designing of Aseptic Area

-  An aseptic area is a room within a clean area designed, constructed, serviced and used within the intension of preventing microbial contamination of the products.

- Aseptic technique are used to prevent the acess of microbial and particulate contaminmation into opthalmic and parentral products.

- The aseptic area is divided into four main grades according to their operations :- 

   a) Grade A - The local zone for high risk operations, eg. filling and making aseptic transfer.

   b) Grade B - Background area of Grade A processes, eg. aseptic preparation and filling.

   c) Grade C - Preparation of sterile solution to be filtered.

   d) Grade D - Handling of components after washing.

⬪ Factor for Designing of Aseptic area/Clean room 

- In aseptic area, all doors should be airlocked.

- Aseptic area should as far as possible from normal areas to avoid unrelated persons.

- All surfaces, walls, roofs should be smooth, unbroken, free from any cracks to minimize the  deposition of microbial cells.

- Sliding doors not allowed for aseptic area, Swings doors allowed which is airlocked and should be open in the flow direction of air ( positive air pressure to negative air pressure ) (positive in room).

- Two doors can not be opened simultaneously (for prevent this warning alarm system should be there).

- All utilities ( pipes, ducts etc.. ) should be installed in such a way that they do not create recesses, unsealed opening.

- Changing rooms should be designed as air locked and physically separated to minimize microbial contamination.

- A filtered air supply should be used to maintain a positive air pressure relative to surroundings.

- HEPA ( High Efficiency Particulate Air ) filters should be installed to filter the air and then which is supplies to the aseptic room. (Pore size 0.2 micron).

- It passes the air in aseptic area, which is free from microorganism.

fig.          Layout Of Aseptic Area

For Watch Video on this topic 👇👇

Simple Explanation in Hindi 

Click Below On Image 👇

to be continue....