A major challenge in laboratory, clinical and small-volume manufacturing environments is the ability to find low-risk packaging components that are easy to use and can help mitigate concerns with container closure integrity. The West Ready Pack system is the solution for these issues. Each sterile Ready Pack system comes with West stoppers, Flip-Off^® seals and your choice of glass or Daikyo Crystal Zenith^® resin vials; these components have a track record of successful commercial application.

World-Class Components

The Ready Pack system is suitable for low-quantity filling of high-value drugs. The stopper components are conveniently packaged in quantities of 500 each (20mm finish) or 1,000 each (13mm finish). Stoppers are available for both serum and lyophilized drugs.

Vial options include sterile Daikyo Crystal Zenith resin and glass from Type I borosilicate glass, a standard for packaging drug products. 

Recent market recalls have been caused by glass breakage, delamination and particulate.  These issues could adversely affect the health of patients and create a serious financial burden on the drug manufacturer.  A Crystal Zenith vial offers a solution to these problems.  Manufactured from a break-resistant cyclic olefin polymer, Crystal Zenith resin vials are ideally suited for packaging high-value biopharmaceuticals or those requiring low-temperature storage or shipping.  In addition, Crystal Zenith resin vials can help keep your drug pure by reducing exposure to leachables and silicone oil.

Read West’s scientific poster, “Detecting Siliceous Flakes in Glass Containers using Microscopic Techniques” or visit Tech News & Views for more detailed information about siliceous flakes. Visit www.WestPFSsolutions.com for additional information and solutions.

Options include:

• 2mL and 5mL Daikyo Crystal Zenith vials
• 2mL, 3mL, 5mL and 10mL glass vials

In addition, West Flip-Off seals help maintain container closure integrity and are engineered to provide tamper-evident packaging.  Ready Pack Flip-Off seals are also available in a copolymer formulation for low-temperature applications.

Ideal for Small-Volume Filling

The Ready Pack system is ideal for pharmaceutical research and development and clinical work. Because the components are packed in small volume, you can order an appropriate quantity for your project and won’t have the worry of being left with a large amount of unused and unwanted stoppers, seals and vials.

The sterilized components are delivered in packaging appropriate for aseptic filling and terminal sterilization, if needed. Because the components are delivered ready to use, you can eliminate component preparation from your processing, saving time and money.

Consistent Value in a Multi-Faceted Solution

A major concern when transitioning from small-volumes through development, regulatory approval and commercialization is the consistency of critical packaging components. The components supplied with the Ready Pack system provide a multi-faceted solution:

• The stoppers feature West FluroTec^® barrier film to improve closure compatibility with the drug product
• The stoppers are washed by the Westar^® ready-to-sterilize process and steam sterilized by the Westar ready-to-use process. These validated processes assure that the components are prepared consistently. Additionally, these processes comply with international standards and current regulatory requirements.

No matter what configuration you choose, West Ready Pack components provide a solution for risk mitigation, change control strategies and Quality by Design initiatives, so you can rest assured that your drug product and its packaging maintain a consistent profile from clinical stages through commercial development.

Ready Pack^®, Flip-Off^®, FluroTec^® and Westar^® are 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.