contractpharmaAugust 31, 2018
Tag: Prince Sterilization Services , Gibraltar Labs
Operating under Gibraltar Laboratories since 2015, the sterilization services division has spun-off into its own entity, Prince Sterilization Services, LLC. The decision to formally separate the companies comes from the early success and plans to scale the sterilization business. Since its inception in 2015, Prince has entered into business contracts with 67 pharmaceutical and 32 medical device companies, as well as some of the largest compounding pharmacies. The company provides contract moist heat steam and dry heat sterilization and depyrogenation services to the pharmaceutical, biotech and medical device industries.
The Prince Sterilization Services management team is led by Dr. Daniel Prince, chief executive officer and Derek Prince, president.
"The use of steam or dry heat to terminally sterilize pharmaceutical drug products and manufacturing components is critical to aseptic manufacturing," said Derek Prince, president of Prince Sterilization Services. "Our customers are looking to satisfy the strictest of sterilization requirements that in-house programs cannot often meet."
Prince Sterilization Services operates its sterilization business in FDA registered, cGMP and ISO cleanroom space. Outfitted with a variety of water for injection (WFI) and air-over-pressure (AOP) equipped steam sterilizers, Prince Sterilization provides customers with terminal moist heat steam sterilization of filled drug products including vials, syringes and blow-fill-seal containers. Similarly, Prince Sterilization performs sterilization of critical manufacturing items such as cell culture bags, bottles, and other materials and equipment. Dry heat sterilization can also be performed on items that are less sensitive to heat or potentially compromised by water.
Prince Sterilization also specializes in the depyrogenation and sterilization of pharmaceutical grade vials, seals and stoppers. Branded as the SteriKit®, Type 1 glass vials, seals and stoppers are WFI rinsed, depyrogenated or sterilized, and aseptically packaged under ISO 5 conditions. After processing, these products are clean room-ready and are certified as particulate free (USP <788>), endotoxin free (USP <85>) and sterile (USP <71>).
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