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The FDA recognizes that compounded drugs serve an important role for patients whose medical needs cannot be met by FDA-approved drugs. However, compounded drugs are not approved by the FDA and therefore, have not been evaluated for safety or efficacy. Poor compounding practices or unsuitable manufacturing conditions can lead to serious adverse effects, or even patient death. Over the past few years, the FDA has taken significant steps to modernize and clarify policies related to the quality of compounding in an effort to ensure continued access to compounded drugs, while also protecting patients from the risks of contaminated or otherwise harmful products1. FDA Draft Guidances2, 3 help to clarify applicable regulatory requirements and specifically address the use and handling of container closure systems.
The FDA highlights uncontrolled sterilization practices as an area of special concern for compounding pharmacies, citing use of non-standard equipment, lack of proper gowning and product handling methods, and failure to use sterilized primary containers and closures to fill sterile products.4 These challenges are not unique to compounding pharmacies; drug manufacturers as well must demonstrate proper sterilization. However, specific challenges for compounding pharmacies result from smaller component quantities, e.g., what is the right test reference sample size if the component batch to be sterilized is relatively small.
West offers a solution with Ready Pack™ containment system, which consists of sterile, ready-to-use (RU) NovaPure® stoppers, Daikyo Crystal Zenith® cyclic olefin polymer vials and Flip-Off® CCS seals. As small-scale, fully-integrated vial containment systems tested for good container closure integrity (CCI) performance, Ready Pack system components work together, but can also be purchased separately. Sterile RU Ompi EZ-fill® vials are also available for customers who need glass. Compounding pharmacies that use Ready Pack components can operate3 with the knowledge that West provides a Certificate of Analysis (COA) and underwrites the sterility of the components. The risks, as well as the work, around component preparation is are reduced and simplified.5
West is committed to the safe and efficient delivery of drug products. For more information, contact an Account Manager or Technical Customer Support (TCS) representative.
Ready Pack™, NovaPure® and Flip-Off® are trademarks or registered trademarks of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.
Daikyo Crystal Zenith® is a registered trademark of Daikyo Seiko, Ltd.
Daikyo Crystal Zenith® technology is licensed from Daikyo Seiko, Ltd.
EZ-fill® is a registered trademark of Nuova Ompi srl.
Today I am a Senior Vice President at Novo Nordisk one of West’s biggest customers. <br /> <br />A few years ago, I used to work quite closely with the West team. I clearly remember my first negotiations with West. Our interactions gave me the feeling that your team members had a deep understanding of our patients, the urgency of the particular matter we were negotiating about. I was under no mistake that their attitude and behavior towards my organization demonstrated a thorough wish to continue working together for many years to come.
For the past 10 years, Janet Cooper, Manager, Admin Services, Exton, has done it all at Canine Partners for Life: from cuddling puppies in the kennel, to giving demonstrations, to serving on the Board of Directors.
The coring and fragmentation of elastomer components used in containment of parenteral drug products continues to be a challenge. Many factors influence these phenomena, so it is critical that a pharmaceutical manufacturer understands how a vial system will be used, for example: what is the recommended needle gauge; is it single- or multi-dose; could spikes, vial adapters or closed system transfer devices be used. Cores and fragments can be generated by needle penetration of the elastomer components. Cores are formed by the needle cannula cutting the elastomer – ordinarily they are cylindrical. Fragments are formed via an abrasion phenomenon of the needle penetration – shapes are irregular. <br />
Exposure to light is a concern with numerous medications due to the potential for photodegradation or other chemical reactions during manufacturing, storage, and administration<sup>(1)</sup>. This may result in potency loss, altered efficacy and adverse biological effects. The sensitivity of a drug to a distinct spectral region of light may vary with its chemical structure, photoreactivity, and nature of the dosage form. The photochemical behavior of a drug provides guidance for handling, packaging, and labeling of drug products. The use of the appropriate containers and packaging material can protect the products from the deleterious effects of light.
In its 95+ year history, West has developed and marketed a very large number of elastomeric formulations, each designed to address particular market demands. Over this time, various aspects of drug product quality have gained attention – a fact reflected in the numerous regulatory guidances that have been issued. An early focus of these guidances was extractables and leachables, followed closely by particulate matter and container closure integrity. Beyond these regulatory requirements, the market demands product portfolios that enable platforming and predictable, consistent product quality and performance.
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