Ready-to-Use Cartridge Components May Help Insulin Manufacturers

The market for prefillable syringe systems (PFS) is growing at a rate of approximately 10 percent per year, with cartridge-based systems growing even faster at rates of 13 percent (2013 market outlook, IMS). The predominant areas of growth are within the insulin and biologics therapeutic areas, as well as overall growth within emerging markets.

As patient needs evolve based on convenience, ease of use and home delivery of injectable drug products, prefilled drug delivery solutions, including injection systems based on prefilled cartridges will continue to grow. New device technology for self-injection will allow for safe administration, flexible dosing and, potentially, better patient compliance.  An example of a common drug product delivered in cartridge form is the insulin product Lantus®, which uses the SoloSTAR® pen device.  Lantus SoloSTAR demonstrates the benefit of cartridge delivery paired with a device by leveraging the “dial a dose” feature and ease of use offered by a pen injector as well as the small thin needles required for injection.  Lantus SoloSTAR also provides more dosing units per prescription compared to single dose vial and syringe delivery which provides patients with more medication for the same co-pay.

Cartridge components

For pharmaceutical manufacturers, new fill-finish technology allows for a flexible design to fit multiple container systems (vial, PFS, cartridge). However, component processing is a source of risk for cartridge components, just as it is for syringe or vial components.  To help simplify drug development and streamline manufacturing, pharmaceutical manufacturers should select cartridge plungers and lined seals in ready-to-use formats.

West’s industry proven Westar® component processing reduces the risk of variability and the potential effects on drug quality, safety and efficacy. Westar RU cartridge components include 1.5mL and 3mL cartridge plungers and 8mm monolayer lined seals (for puncture applications less than five punctures) and 8 mm laminate lined seals (for greater than five punctures).

These product offerings are ideal for companies developing new products in the insulin space or for companies with existing insulin products that understand the advantages associated with ready-to-use components. The laminate-lined seal is designed especially for insulin products requiring multi-dose applications and has been tested at greater than 100 punctures.

For more information on West’s prefillable solutions and Westar cartridge components, visit: http://www.westpharma.com/en/products/Pages/CartridgeComponents.aspx

Author:

Royce Brockett
Senior Product Manager
Royce.Brockett@westpharma.com

Lantus® and SoloStar® are registered trademarks of sanofi-aventis U.S. LLC

Westar® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.

They Might Be More Than Just Secondary Closures

Today’s regulatory guidelines and requirements for pharmaceutical manufacturers are getting more specific and stringent, ensuring that drug products are safe and that there is no compromise with the possible use of unsuitable and/or non-compliant packaging components. For instance, regulatory guidelines require use of clean components (inclusive of secondary seals for this context) for sterile filling operations.

The U.S. Food and Drug Administration (FDA) Aseptic Guide, section A. Components states: “Knowledge of the bioburden is important in assessing whether a sterilization process is adequate.”

Likewise, from European Medicines Agency (EMA) Annex 1, clause 80 states:

The bioburden should be monitored before sterilization. There should be working limits on contamination immediately before sterilization, which are related to the efficiency of the method to be used. Bioburden assay should be performed on each batch for both aseptically filled product and terminally sterilized products…

Clause 118 offers the following guidance: “The container closure system for aseptically filled vials is not fully integral until the aluminum cap has been crimped into place on the stoppered vial.”

As one of the pioneers to the pharmaceutical packaging industry, West introduced Flip-Off® (FO) CCS – Clean, Certified and Sterilized seals to meet pharmaceutical manufacturers’ needs for clean secondary closures in sterile filling operations.

FO-CCS seals are ready-to-use (RU) products sterilized by gamma sterilization. They are certified for bioburden (prior to sterilization) and particulate, meeting the requirements from EMA Annex 1.

To learn more these clean components, contact your account manager today!

Author:

Boo Jia Min
Technical Support
JiaMin.Boo@westpharma.com

Flip-Off CCS® is a registered trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.

West Receives 510(k) Clearance for NovaGuard™ SA Safety System

Staked-needle prefillable syringe safety needle system helps reduce risk of needlestick injury to healthcare workers and patients

The World Health Organization (WHO) estimates that each year healthcare workers incur two million accidental needlestick injuries that may result in infections with hepatitis B and C, HIV and other diseases.[1] To help prevent the spread of bloodborne infectious diseases, effective drug administration techniques and delivery systems must prevent needlestick injuries.

Injectable drug delivery systems that incorporate a safety mechanism can reduce the risk of accidental needlestick injuries significantly. West provides a solution with the NovaGuard SA (Staked-needle Automatic) safety system, which recently received 510(k) clearance from the United States Food and Drug Administration. The NovaGuard SA safety system helps reduce the risk of needlestick injuries by shielding the exposed needle of a prefilled syringe after use.

NovaGuard SA

“West has deep expertise in needlestick prevention and a portfolio of offerings that enable safe and effective drug administration,” said Graham Reynolds, Vice President, Marketing and Innovation. “It’s our hope that the NovaGuard SA safety system is used as a cost-effective solution to help improve needle safety.”

The NovaGuard SA safety system helps protect patients and healthcare workers by shielding a syringe’s exposed needle once activated. The NovaGuard SA safety system is suitable for prefilled ISO standard glass syringes and features a tamper-evident needle shield feature that can reduce flange breakage. It is part of West’s NovaGuard family of syringe safety technology offerings.

For more information visit West’s website.

NovaGuard™ is a trademark of West Pharmaceutical Services, Inc., in the United States and other jurisdictions.

[1] Wilburn S, Eijkemans G. Preventing Needlestick Injuries among Healthcare Workers: A WHO–ICN Collaboration. Int J Occup Environ Health. 2004;10:451–456. Available from: http://www.who.int/occupational_health/activities/5prevent.pdf

Freeze! Froze! Frozen!

The glass transition temperature (Tg) is the temperature at which a material loses its viscoelastic properties. It is also indicative of the lowest temperature at which the polymer system will retain its functionality.

The typical Tg for polymer used in the general industry is approximately -50oC. For drug product that requires storage at cold temperature, below the Tg of the rubber, the hard surface of rubber would be seated against the hard surface of glass. This may affect the container-closure integrity (CCI), causing a potential for microbial ingress and gas headspace exchange. Customers should perform proper functionality testing of the stopper with emphasis on seal integrity on the product package intended for storage at these temperatures. Currently, there is no test method available for CCI at -80oC. The typical approach is to prove CCI and sterility prior to storage below -80oC. Rubber has ‘memory’ and so it is recommended for retest after bringing back to ambient to prove no impact to CCI or sterility .

In addition, the Tg of the PP buttons used on the Flip-off seals is approximately -20oC. Below which, premature removal of button may occur during shipping. West offers ‘copolymer’ buttons. Copolymer is a more robust material and limits early activation of button during shipping. Copolymer seal is made of PP with small amount (<10%) of PE added. PE helps the seal from becoming brittle during cold storage. The copolymer seal performs at -80oC. Further investigation would be required for storage below -80oC using the copolymer seal.

West offers packaging components tested to be suitable for cold temperature storage (-80°C or dry ice) and for transport in dry ice. Please contact your account representatives for more information for the appropriate recommendations.

Author:

Tan Shi Min
Senior Technical Support Engineer
shimin.tan@westpharma.com

Spotlight on the Common Failure Points of Sterile Barrier Packaging Validations

In a product’s development lifecycle, the importance of packaging can sometimes be overlooked until a packaging specialist becomes involved and can elucidate whether the packaging design is suitable and meets the tests for form, fit and function. Some companies that may not understand or emphasize the critical elements of a good package in the design phase may find out too late that the package is unsuitable after sustaining one or more failures during validation testing.

Once company experts have established the right packaging around the product configuration, then it must adhere to the design requirements. This is where preliminary testing through design of experiments (DOEs) or packaging engineering studies comes in.

Several items need to be considered before package testing can begin such as sample size, test method(s), acceptance criteria, dunnage[1] material or product, use of controls, thermal conditioning (hot and/or cold), transportation simulation testing and cost to name a few. What combination of variables you choose in a packaging test validation procedure can be based on a properly done risk assessment. So to arrive at that perfect combination is just the beginning.

So what if your packaging fails to perform as expected? Just because you had a test failure does not automatically mean that the packaging is inadequate. It does, however, demand evaluation and adjustments. A great place to start investigating a packaging failure is with the four most common failure points encountered in sterile barrier packaging validations.

  1. Oversealing
  2. Tears/pinholes
  3. Packaging Configuration
  4. Compatibility with Sterilization

 

Author:

Ralph Nigro
Project Specialist, Packaging Development
Ralph.Nigro@westpharma.com

[1] Dunnage was originally defined as loose materials used to support and protect cargo in a ship’s hold. That was when shipping vessels were the only form of international shipping. In the packaging industry it is material that provides padding in a shipping container that may or may not be representative of .

Diane Paskiet to Speak at E&L Europe 2014

Diane Paskiet, Director Scientific Affairs, will provide an update on the PQRI-PODP working group at the Smithers Rapra Extractables and Leachables conference in Barcelona, Spain on November 10-12, 2014.  Diane serves as chair of the Product Quality research Institute (PQRI) Parenteral and Ophthalmic Drug Product  Leachables and Extractables Working Group and will present the objectives of the group and application of Thresholds and Best Practices to Prefilled Syringe components at a session on Tuesday, November 11.  PQRI extractables data from common packaging materials and toxicological assessments will also be displayed.

The conference will include presentations on:

  • The European Regulatory Perspective
  • Case studies of E&Ls in infusion pump systems and pre-filled syringes
  • Extractables and Leachables testing – The BioPhorum Operations Group protocol
  • Extractable and Leachable studies of a Pre-filled Syringe (PFS) used for delivery of a cancer-treatment drug solubilized with high content of castor oil surfactant and alcohols
  • Comparison of methodologies for extractables assessment
  • Elemental impurities from materials used in pharmaceutical applications
  • And more!

To learn more or register to attend, visit: http://www.eandl-conference.com/extractables-and-leachables.aspx

 

Pennsylvania Bio Presents “Start with the End in Mind”

A West-Sponsored presentation on Monday, November 10, 2014.

Looking to optimize your delivery system to help reduce time to market, manage risk, lower costs and improve patient outcomes? Then join West’s Graham Reynolds, Vice President of Marketing and Innovation, who along with Sherry Martin-Moe, Ph.D Executive Vice President at Enterprise Catalyst Groupand Yen-Heui Lin, Ph.D. Head of Drug Product Sciences, Global CMC Biologics at Teva Pharmaceuticals, will present “Start with the End in Mind.” The presentation will cover:

  • How early decisions on containment and delivery systems can be instrumental to success
  • Alternative containment materials that can help limit surprises like unexpected chemical interactions and improve time to market
  • Key advantages provided by advanced, flexible, customizable delivery options that may improve patient adherence and quality of life

When: Monday, November 10 8:30 a.m. – 10:30 a.m.

Where: Shire Pharmaceuticals, Chesterbrook Conference Center, 1400 Liberty Ridge Drive Suite 106 Wayne, Pennsylvania 19087

Register now: http://www.cvent.com/d/p4qtmp

We’ll see you there!

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