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Medical
Device Management Services
The
Alpha Quality Consulting team has a strong background in gamma
sterilization, ethylene oxide sterilization, USP/AAMI microbiology
testing, steam sterilization of medical devices, pharmaceuticals,
and biotechnology products, offering consulting services in the
following areas:
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Gamma
sterilization validation per ISO 11137, ISO 13409, ISO 15843,
and AAMI/TIR 27. |
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Ethylene
oxide sterilization validation per ISO 11135. |
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Steam
sterilizer validation per ISO 11134. |
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Validation
of USP/AAMI microbiology test methods. |
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Preparation
of validation protocols, performance of validation, review
of data, and preparation of validation final reports. |
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Preparation
of SOPs or work instructions for: daily sterilizer production
loads and review of sterilization cycles, laboratory procedures
for validation, training, and daily performance of SUP microbiology
and AAMI microbiology test methods (this would include items
such as bioburden, sterility testing, bacteristasis/fungistasis
testing, LAL gel-clot endotoxin testing, MEM-elution biocompatability
testing, microbial limits test, preservative effectiveness
test, biological indicator testing, viral penetration test,
etc.) |
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Review
of microbiological environmental monitoring procedures for
medical products manufacturing areas. This would also include
bacterial monitoring of purified water systems. |
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Also
experienced in cell culture/tissue culture laboratory operations. |
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