Q: Define & classify clean room.
Clean room can be defined as a room in which the concentration of air borne
particles is controlled with specified limit.
Classification of clean room:
According to British standard clean room can be classified into two.
Particle size (p) Class No .per ft2
0.5 1 86
5.0 - 0
0.5 2 8495
5.0 - 57
10.0 - 0.08
Q: Define Pyrogen. What are the sources of pyrogen?
Pyrogens may be a combination of hexosamine, a reducing sugar and a non-reducing carbohydrate portion or it may be a proteinous metabolic end product. Pyrogens are more of often produced by gram negative than by gram positive organisms. They may also be caused by yeasts & molds. The size of pyrogen varies from 50mp to 1 p.
Sources of Pyrogens:
• Pyrogen containing vehicle
• Pyrogen contaminated solute
• Pyrogen contaminated equipment
• Air borne bacteria during the preparation of the product
Q: Classify water.
Ans: USP specified five degrees of water. These are-
(i) Water USP: Water USP is used in the washing and extraction of crude drugs in the preparation of products for external use.
(ii) Purified water USP: Purified water USP is used in the preparation of all medication containing water except ampoules injections etc. This water is prepared by distillation and PH is about 5.6.
(iii) Water for injection USP (WFI): This water is pyrogen free water purified by distillation for the preparation of parenteral products.