Pre-filled syringes are increasingly being used as the […]
Pre-filled syringes are increasingly being used as the container closure system of choice for biological agents. It must provide a complete barrier to protect the stability and sterility of the drug product throughout its shelf life.
Drug manufacturers are required to check and prove that the system maintains the integrity of the microbial barrier. In 2008, the FDA further enhanced container seal integrity (CCI) testing as part of the Stability Product Stability Agreement.
In response to increasingly stringent regulatory expectations, the pharmaceutical industry has driven and witnessed significant technological advancements in CCI testing. Instrument-based technologies such as high-voltage discharge detection (HVLD), vacuum / pressure attenuation, large-scale extraction, and missing gas detection (helium, oxygen, etc.) have emerged, proving that detection capabilities are improved compared to traditional staining methods and microbial invasion methods. Many technologies have been used for online 100% inspection and / or drug stability CCI testing. We tried to design a systematic method for the selection, development and verification of CCI test methods.
To play a role in both the container sealing system and the drug delivery device, pre-filled syringes feature many unique design elements. They usually include multiple container cavities sealed by numerous interfaces. For example, current glass syringes with needles provide a syringe barrel cavity for medicines and a separate needle protection cavity to protect the needle. The syringe barrel cavity One end of the body is sealed by a plunger, the other end is sealed by a needle, and the needle tip is inserted into the needle sheath. The syringe needle protection cavity is sealed by the syringe barrel head to protect the outer surface of the needle from potential contamination. During the development of CCI test methods, potential failure modes associated with each cavity and seal interface need to be identified, evaluated, and considered.