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If a HEPA filter accumulates too many particles and gets clogged, it may end up in a loss of performance that will compromise the cleanroom's ISO score.b. Your aseptic processing Management programs and operations don't give assurance the manufacturing rooms and equipment preserve aseptic situations.iii. Your validation/revalidations will not docum

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In your response, your company states that (b)(four) Slicing and Packing Device is actually a custom-manufactured unit. The unit contains subunits that accomplish features independently of one another Which modification to at least one subunit isn't going to automatically adversely affect other subunits or perhaps the products in general. You add

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