Injectable Administration Systems - Pharmaceutical Technology

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Injectable Administration Systems
During the past 30 years, manufacturers have developed sophisticated packaging and delivery systems to support the requirements of traditional and complex biologics. Highest among the requirements during this time has been the increased focus on quality and cleanliness. This article discusses the evolution of packaging and delivery systems for injectable administration systems as the pharmaceutical and biotechnology industry evolved during the past 30 years. It also explores the future of packaging and..

Pharmaceutical Technology

Stoppers and syringe plungers are not the only primary packaging components undergoing change. Many new drugs, especially those used for oncology, are sensitive to the glass used to manufacture vials and syringe barrels. Contaminants from the glass might leach into the drug product which in some instances can be worth thousands of dollars per dose. This new generation of high-value biopharmaceutical therapies requires equally high-value packaging and administration systems to maintain the drug's biological integrity and to maximize its therapeutic benefits.

Some manufacturers are switching their products from glass vials and syringe barrels to products manufactured from cyclic olefin copolymers (COC) and cyclic olefin polymer (COP) materials. These resins are inert and have properties such as extremely low extractables, high heat resistance, excellent low-temperature characteristics, excellent drainability, and low-moisture permeability that are favorable for high-potency, high-value drugs.

A deliberate evolutionary process

The transformation to today's primary pharmaceutical packaging environment, with an emphasis on quality and cleanliness, proceeded deliberately with the focus on creating a CGMP environment. From the manufacturing floor and into a company's day-to-day operating procedures, CGMP regulations represented a huge shift in thinking. They required improved traceability of the raw-materials chain; the introduction of new systems for quality control and quality assurance testing of raw materials, work in progress, and finished goods; and a tightening of manufacturing and operating procedures and product specifications to achieve new levels of quality.

Today's plant has the cleanliness one would expect in pharmaceutical manufacturing. Employees in manufacturing and processing areas wear protective clothing appropriate for the work space's classified environment to keep particulate and fibers out of the manufacturing area, and they are trained thoroughly in CGMP requirements. The quest for quality begins even before raw materials are received at the plant. Materials are purchased on the basis of a supplier's ability to meet tight tolerances and strict quality standards.

Moreover, incoming raw materials are sampled and tested; the lots are not released for production until the laboratory determines that specifications have been met. Today's elastomeric formulations are blended from fewer materials that are less extractable. The formulations used 30 years ago would not be acceptable for new drug products today because of concerns over extractables and leachables and because some of the materials used in the 1970s would not meet current industry guidelines. In addition, the properties of today's elastomers, including coring and resealing properties, help pharmaceutical manufacturers meet shelf-life requirements and provide better performance during administration. Further, today's elastomers have helped improve the manufacturing process. As a result, molding yields fewer rejected parts.

Today, mixing equipment used to blend the ingredients that go into elastomeric formulations is closed to minimize contamination. The calendaring and extrusion processes can achieve tight dimensional tolerances for the sheeting that is used to mold the components. Improved equipment and quality systems such as in-process metal detectors help ensure the highest quality finished components.

Molded sheets of components move from molding to trimming, where a die trims the individual parts from the sheet. Today's trim dies operate at a high level of precision. The result is components with very little dimensional deviation from the standard and fewer instances of particulate from the trimming process.

Postmanufacturing processes also have advanced significantly. In today's manufacturing environment, downstream processing frequently includes washing in a pharmaceutical-grade washer to yield ready-to-sterilize components that are shipped to manufacturers. Final rinse processes use water-for-injection and final packing is conducted in a Class 100 cleanroom. The bags used to pack the washed components are suitable for direct entry into a sterilizer.

The contrast with 1970s processing is striking. Three decades ago, most components were trimmed and dropped into a poly bag. The bag was secured with a twist tie and shipped to the customer in a corrugated box. Component washing was rudimentary compared with today's process; the wash did little more than remove lubricants applied during the trimming operation.

The impact of regulatory guidances

Guidances issued by the US Food and Drug Administration have had a strong influence on the drive to cleanliness and ultrahigh quality.


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