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21 CFR 211.167 (a) For each batch of drug product purporting to be sterile and/or pyrogen-free, there shall be appropriate laboratory testing to determine
Employers should ensure that a risk assessment has been completed and approved for the work to be conducted and to identify the class and type of BSC needed for.
If a pre-existing sink is present in the operating room, a written policy to prohibit the use of the sink during sterile surgical procedures must be in place.
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