Seals

For injectable drug product package systems, seals are considered to be secondary package components. Though not in direct contact with drug products, they perform critical functions such as: Maintain an integral sterile seal by holding the stopper firmly in place, protect the injection site on the stopper and provide evidence of tampering (dependent on seal design).

Customers  frequently ask: Do we need to wash secondary closures, such as West Flip-Off^® seals? Like so many questions, the answer is “it depends”. But in general, the answer is “no”.

Many injectable drug products, such as monoclonal antibodies and recombinant proteins, are susceptible to degradation over time when stored at ambient temperature. As such, they are stored, and subsequently delivered, in a lyophilized state - which enables a much longer shelf life. Lyophilization (also known as freeze-drying) is a process by which all water is removed from a drug product. Absent water, all metabolic processes stop, and drug products thus stored in a lyophilized condition are far more stable. At the time of use, the lyophilized drug product is reconstituted with water (or other appropriate solution) and delivered to the patient.

In recent years, regulatory guidelines such as The European Medicines Agency (EMA) Annex 1 “Manufacture of Sterile Medicinal Products” have influenced the requirements for the seal crimping processes. EMA Annex 1 specifies that the manufacturing of sterile products is subject to “special requirements in order to minimize risks of microbiological contamination.” The EMA refers to two processes in fill-finish area of manufacturing plants performing aseptic filling:  Aseptic Crimping and Clean Crimping.  To ensure compliance, pharmaceutical manufacturers need to select the proper seal for each process.

Uninterrupted production on a high-speed filling line is a challenge. To help make this easier, West has developed Flip-Off^® seals. Flip-Off seals are produced with the highest quality aluminum and plastic materials, and the TruEdge^® manufacturing process.

Color has a surprising number of uses in injectables packaging.

European guidance states that “similarity in packaging which contributes to medication error can be reduced by the judicious use of color on the pack” ¹. Draft guidance issued by the U.S Food and Drug Administration (FDA)² similarly recommends that “sponsors use color prudently to bring attention to the product name, strength, and important warning(s).” Color – when applied thoughtfully and with full awareness of the context in which the drug will be used – can be an important way for manufacturers to help practitioners and patients differentiate products and support their correct use.