processing | Clean compounding
Right: USP Class IV
compliant antistatic blends are
required for use in applica- tions such as medical
electronics and inhalers
which correlates to Federal Standard 209E Class 10,000 or 100,000, respectively. Also, the device company will often expect the compounding facility to be certified to ISO-13485,” Listro explains. “Compounding of drugs and polymers must be done
according to current good manufacturing practices (cGMP) under the FDA’s quality system for manufactur- ing pharmaceuticals (21 CFR parts 210 and 211),” he says. “Requirements for handling and processing drugs in a cleanroom are more stringent than medical devices in order to ensure consistent quality and minimise contamination of or from the active pharmaceutical ingredients (APIs). Further, there are significantly more stringent requirements to receive, store, process and ship drug products. The facility and quality systems must be robust enough to meet these requirements.” Meeting the strict requirements of the pharmaceutical
industry is essential when creating a clean compounding operation. “Compounding cleanrooms should have quartz epoxy seamless floors, dedicated fume and dust collection systems, controlled pressurisation, tempera- ture controls of plus/minus 2°
F (1.1°
processing equipment should address the unique characteristics of polymers and additives for the specific applications. For example, implantable devices com- monly use bioresorbable polymer that may be sensitive to degradation from moisture, while APIs used in pharmaceutical compounding have distinct temperature and physical degradation profiles. Feeder accuracy is extremely important to maintain content uniformity of additives incorporated into the polymer,” Listro explains. As a final point, Listro explains that pharmaceutical
compounding of APIs under GMP quality standards requires either dedicated equipment or following validated cleaning procedures before use of equipment in other applications. “Prior to processing, a coupon study is carried out on coupons having metallurgy similar to the process equipment to make sure the equipment can be cleaned and the drug does not stain or corrode the process equipment. This includes feed systems, barrels, screws and any component that contacts the drug. Also, processing of APIs require dedicated room ventilation to avoid contamination with other parts of the facility,” he says.
Mixed environments As a supplier of custom polymers including compounds, colourants and additive masterbatches, US-based Plastics Color Corporation offers a clean compounding operation in addition to its other facilities. The company says that it has supplied materials for tube filtration systems to IV kits, with a heavy focus on pharmaceuti- cal, nutraceutical and medical applications, requiring a good balance between colourant and additive needs when it comes to clean compounding. When establishing such an operation alongside a
C), humidity controls,
Right: Foster can supply custom
coloured medical grade
polymers using FDA-certified pigments
interlock pass through accesses, and gowning rooms. Compounding equipment should consider the materials to be processed. Several polymers used for implanted medical devices cost $1,000 per pound ($2,200 per kg) or more, and APIs can be even more expensive.” Listro recommends that compounding extruders should be sized to maximise the yield when processing these expensive materials. Twin-screw extruders are a good choice as they allow for maximum mixing and temperature control within a short screw length. Extruder sizes used for compounding biomedical polymers are generally smaller than those used for compounding traditional healthcare or non-healthcare materials. Typical equipment may range from 11-16mm for prototype quantities, up to 27-70mm for scale-up and production duties. Careful consideration also has to be given to all the associated compounding infrastructure. “Auxiliary
18 COMPOUNDING WORLD | April 2016
conventional compounding plant one of the main issues to consider is risk mitigation, according to Jennifer Prensell, Plastics Color’s Corporate Quality Systems and Regulatory Affairs manager. “Eliminating the risk of
www.compoundingworld.com
PHOTO: FOSTER CORPORATION
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