Animal drug produces quality to manage normative appendix

, general principles
1, this appendix is " management of quality of animal drug production is normative " to asepsis animal drug, blame asepsis animal drug, raw material medicine, animal uses biological product, mix agent, Chinese traditional medicine beforehand the production such as preparation and quality management are special the additional provision of the requirement.
2, animal drug produces clean room (area) air is clean degree differentiate for 4 level:

Clean degree of level grit is the biggest allow to count / stere
(static state) microbial the biggest allow to count
(static state) times of air replacement
0.5 μ of ≥ 5 μ of M ≥ M pelagian bacterium / stere sedimentations bacterium / 90 Min of Ф 0.5h
2 of annotations of 100 class 3500 0 5 0.5
≥ of 10000 class 350000 2000 50 1.5 20 / when
≥ of 100000 class 3500000 20000 150 3 15 / when
≥ of 300000 class 10500000 60000 200 5 10 / when

Note: (1) dust particle counts ／ stere, the requirement is right ≥ 0. 5 μ of 5 μ M and ≥ the grit of M all determines, stere of pelagian bacterium ／ and sedimentation bacterium ／ Min, can allow to measure a kind.
(2) 100 class are clean room (area) 0. The sectional lowest wind speed of 8 meters high work area: Perpendicular and one-way flow 0. Second of 25 meters of ／ ; The level is one-way flow 0. Second of 35 meters of ／ .
(3) of clean room determine consult JGJ 71-90 " clean room construction and check and accept a standard " carry out.
3. Clean room (area) management needs to accord with following requirement:
(1) clean room (area) amount of the member that my wife should be controlled strictly, clean to entering room (area) temporarily foreign staff should undertake coach and be supervisoried.
(2) clean room (area) with be not clean room (area) between must install amortize establishment, trend of person, content shedding is reasonable.
(3) 100 class are clean room (area) inside must not install floor drain, operate personnel not to answer naked hand operation, hand ministry should be disinfected in time.
(4) transmission equipment should not be in the strong poison of 10000 class, vivid poisonous biology is clean room (area) and Jiang Zhimin sex is clean room (area) with elementary and other clean room (area) between pass through, the mouth of a cave of transmission equipment should assure air current from pressing side to flow to side of opposite negative pressure relatively.
(5) the clean coverall Ying Zaijie of area of 100000 class and its above is clean room (area) inside catharsis, dry, arrange, should press requirement sterilization when necessary.
(6) clean room (area) inside surface of equipment heat-insulation layer should level off, bright and clean, must not graininess material falls off.
(7) clean room (area) appraisal or check and accept detect, ask to the dust particle number of diameter of two kinds of bead and pelagian bacterium are counted or sedimentation the either in bacterium is planted the regulation that all must accord with static condition to fall as a result is numeric, still should monitor the clean state below dynamic condition regularly in addition.
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