Comparison of cleanroom and isolator aseptic processing technology for small start-up parenteral facilities
Burton, Shannon Lamb
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The sterility of drug products in the United States is of utmost importance when it comes to patient safety. Drug products, which cannot be subjected to terminal sterilization, must be brought together in their final form utilizing aseptic processing technologies such as cleanrooms and isolators. This thesis provided a comparison of cleanroom and isolator technologies relative to the current regulations (21 CFR 210 and 21 CFR 211) and applicable guidance documents (FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice, ISO 14644 Cleanrooms and Associated Controlled Environments, ISPE Baseline Guide – Sterile Manufacturing Facilities) and a cost analysis to determine the overall financial impact to the manufacturer. The research demonstrated that isolator technology is more cost effective and advantageous for a small start-up parenteral facility and is therefore the superior technology.