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processing | Clean compounding


Above left: This image shows the 12ft wide filter bank in a horizontal laminar flow cleanroom installation


Above centre: A horizontal laminar flow cleanroom configured for multi-stage operations


Above right: A cleanroom technician working at a laminar flow clean bench in a compounding cleanroom


says. “In addition, the design and layout of the extruder must mean that operators do not violate or contaminate product being produced. It is also essential that cleanroom personnel assigned to the extruder are garmented in a complete coverall, hood, gloves and face mask as necessary, and employees are formally trained in cleanroom operations by outside-qualified cleanroom trainers. Finally, standard operating procedures must be prepared and followed for all operations.” Discipline in dealing with raw materials from


suppliers as well as finished product is just as impor- tant. “No pre-cleaning activities can be performed in the cleanroom,” he adds. “For example, materials in cartons from suppliers must be cleaned outside the cleanroom or in the air lock. Raw materials should be purchased with a cleanliness specification. That cleanliness should be certified by the shipper including material batch numbers for all raw materials, and incoming inspection should verify the cleanliness specified on the Purchase Order. The finished product must be protected against contamination by clean bagging or clean containers from the time it leaves the extruder until it reaches its user endpoint.” Austin emphasises that many operations fail because


operating personnel do not understand fine particle contamination. “Contamination is often thought of in the light of everyday practices. Fine particle contamination in cleanroom compounding operations is a minimum of several orders of magnitude smaller and finer. However, it is also many orders of magnitude greater in the quantity of particles present in the production environ- ment. A 25 micron size particle (0.001 inch) is barely visible to the unaided eye with 20/20 vision. However, such a particle in a transparent plastics extrusion or clear compounding product under white light inspection is readily visible and cause for rejection,” he says. “People in the cleanroom compounding operation


business are unaware of the existing personnel contami- nation table called the Austin Contamination Index which relates to personnel activities under specific cleanroom garmenting and their personnel particle emissions. For example; a person with no activity gowned in a clean- room smock emits 100,000 particles per minute. A


16 COMPOUNDING WORLD | April 2016


person in a one-piece coverall reduces this emission amount by a factor of 10 to a rate of 10,000 particles per minute. A two-piece Dacron coverall reduces this emission amount to a rate of 4,000 particles per minute. Gowning does pay benefits in reducing the amount of contamination injected in and about the product during the manufacturing cycle,” Austin explains.


Biomedical compounding Specialist producer of biomedical polymers and compounds Foster Corporation operates three facilities in the US - two for the manufacture of engineered polymer materials for medical device technologies and one for compounding materials for pharmaceutical and combination products. Tony Listro, Vice President Delivery Science, explains that cleanroom polymer compounding for healthcare applications may encom- pass processing of a wide range of materials for applications with varying requirements. Three notable applications include polymer compounding for implant- able medical devices, compounding of drugs and polymers for combination products, and pharmaceutical extrusion of drugs and polymers. “First and foremost, quality systems are essential for


cleanroom compounding for these applications. This includes quality leadership, staffing and training. These quality systems will depend on the applications for which the materials are being processed,” he says. Quality systems are typically defined by the customer – whether that be a device manufacturer or or a medical processor – according to recognised standards. “Custom compounding of device polymers without drugs, such as those used for implants and/or Class III devices, is often performed as a sub-tier operation to a medical compo- nent manufacturer or a medical device company. The device company is required to follow the quality systems designated by the FDA in the Code of Federal Regula- tions Title 21 Section 820 (21CFR820), which include establishing environmental controls and procedures that ensure adverse effects on product quality are mini- mised. Requirements of the compounding facility are, in turn, designated by the device manufacturer. The facility requirements are more often ISO 14644-1 Class 7 or 8,


www.compoundingworld.com


PHOTOS: ACORN INDUSTRIES


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