Drug Sterilization

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• Drug Makers Fight Back!
  Manufacturers take different approaches to selecting anti-counterfeiting technology, with some emphasizing detection and others deterrence, says Richard Jotcham, Director of Technology Services for of Axess Technologies Ltd. in the U.K, a partner in the Product Surety initiative. "Each drug needs...
• Minimizing Risk in Sterilization Validation
  . Articles. White Papers. Products. News. Member Login. Become a Member. Home. Topics. Aseptic Processing. Automation & Control. cGMPs Compliance. Contract Manufacturing. Drug Delivery. Facilities & Support. Facility of the Future. Fill Finish. Focus on Pharma Podcast. Funny Pharm. Green Library...
• Selecting Modulating Valves and Clean Steam Traps for Sterilization in Place (SIP) Systems
  . Food and/or Pharmaceutical Grade Soft Goods. The sealing materials should be approved by the local food and drug agencies. Most. manufacturers provide elastomers conforming to the US FDA (US Food and Drug. Administration) code Title 21, Paragraph 177 which permits repeated use in contact with. food...
• Combination Products: Navigating Two FDA Quality Systems
  be problematic, due to drug/biologic and sterilant incompatibilities. Radiation and ethylene oxide sterilization cycles may degrade drug/biologic characterization and potency. Impurities may actually increase due to these harsh process parameters. Aseptic processing, for instance, coating drug products...
• Amgen: Do Electron Beams Impact Large Molecules?
  to the drug product. One such company is Amgen, which has studied potential irradiation of proteins during syringe tub sterilization. The findings so far: no significant impact, which is illustrated in the following poster, presented at the 2008 ISPE Annual Meeting in Boca Raton, Florida. To cast your...
• Electropolishing Improves Lead Screw Surface Quality
  , shearing, and tearing action of mechanical stock removal and abrasive finishing. Removes excess material as desired for milling metal parts. Improves surfaces for use in sterilization in the drug industry, surgical equipment, dairy and food equipment, restaurant equipment, missile and rocket parts...
• Disposable Processing Equipment Update
  Disposable process equipment, once a tiny niche market, has seen dramatic growth in the past few years, as drug manufacturers adopt single-use systems to reduce cleaning, sterilization and their associated validation costs. A recent study by Stedim and Biopharm Services [1] found that shifting from...
• Tech Transfer: Don't Fumble the Hand Off
  in the reactor train. As you gain more experience with PAT, you recognize these as standard issues, says Grosso. Baxter BioPharma Solutions (Round Lake, Ill.), which contract-manufactures premixed parenteral drugs in flexible plastic containers, has become a specialist in frozen premixed drug...
• Low-Energy Electrons Have Pharma Beaming
  | Pharmaceutical Manufacturing. Digital Magazine: Read / Subscribe. RSS. Contact Us. Advertise. All. Articles. White Papers. Products. News. Member Login. Become a Member. Home. Topics. Aseptic Processing. Automation & Control. cGMPs Compliance. Contract Manufacturing. Drug Delivery. Facilities & Support...
• Can 13 Years of FDA Data Teach Us Anything?
  This quick, one-time registration gives you access to members-only site benefits. Fact or fiction? Pharmaceutical plants that make prescription drugs have a greater likelihood of being inspected than those making non-prescriptions. FDA drug investigators with increased training find more acts...

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