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The US Food and Drug Administration (FDA) has published Federal Regulation 21 CFR Part 820, Quality System Regulation. This regulation follows ISO 9000. More specific to the clean areas and cleanrooms of interest are the standards and drafts under ISO 14644. A good overview of these standards is available on the IEST web site. Similarly, European Standards provide European Nations with guidelines for GMPs.
Why do these GMPs matter with regard to air filtration in manufacturing processes for pharmaceutical, bio-pharmaceutical and medicinal products? Because GMPs require that the quality of these products be assured, including the control of product contamination during manufacturing and packaging. Generally speaking, the control of contamination is most critical for injectable or parenteral preparations as compared to topically applied or orally ingested preparations. Eye drops, which can be considered a topically applied preparation, are an exception to this rule as the eye is regarded as not susceptible to infection.
Visit the recommendations page to learn which filters Camfil Farr recommends for your application.
Download segment brochure here (pdf).