Flip-Off® Seal Family of Products Attracts Growing Number of Pharmaceutical Manufacturers
Known for a commitment to excellence in elastomeric components, West has complemented its vial closure portfolio with the Flip-Off® seal brand. Particularly in its ability to provide solutions for aseptic and clean crimping, the Flip-Off seal demonstrates potential to become an industry standard.
The highest quality offering is the Flip-Off® CCS seal. It is used for aseptic crimping and its name reflects the key product attributes: Clean, Certified and Sterilized (CCS). Customers crimping in an aseptic area are looking for a low specified particle level (in line with grade A classification and comparable to ISO 5 guidelines)1,2 and a pre-specified bioburden prior to sterilization. These features, combined with an optimal seal manufacturing process, give pharmaceutical manufacturers the option of smooth, clean operation within an isolator.
Flip-Off® Plus is the newest member in the Flip-Off seal portfolio and is designed to meet the needs for clean crimping outside of the aseptic core under Grade A, but under constant Grade A air supply (laminar flow)². Although less stringent regulations apply for the clean crimping process compared to crimping in an aseptic area, the Annex 1 of EMA regulations require a specified bioburden for sealing². Flip-Off Plus was launched to support fill-finish operations to comply with the needs for bioburden speciation and offer a high-quality, easy to use component for drugs marketed within the EMA jurisdiction and beyond.
For pharmaceutical customers, West delivers consistency and reliability. The same high-quality standards are applied to all sterilized seals and elastomeric components. These offerings are ready to be processed immediately and guaranteed to meet tight component quality levels, which may reduce complexity in an already highly complex pharmaceutical manufacturing environment. Additionally, relying on West products and services can potentially reduce downtime and simplify inventory management.
Click here to learn more about the Flip-Off seal brand.
- Remington: Essentials of Pharmaceutics; Michael J. Akers, PhD (2013), Chapter 26 Parenteral Preparations, p. 495-532
- EUROPEAN COMMISSION; EudraLex; The Rules Governing Medicinal Products in the European Union; Volume 4: EU Guidelines to Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use; Annex 1: Manufacture of Sterile Medicinal Products.