Container Closure Integrity Testing (CCIT): Solutions for the pharmaceutical industry
Sensitive drugs require packaging for prevention of moisture or oxygen or microbial contamination.
The quality and effectiveness of drugs significantly depends on their proper packaging: Sterile products and moisture/oxygen sensitive drugs require excellent barrier during the shelf life of the product (up to a couple of years) to protect them from biological contamination, water and oxygen ingress. Otherwise, serious consequences might occur. This was proven by a grave incident in the 1970's: During this period, contaminated intravenous fluids packaged in glass bottles – which were typical at the time for packaging such dosage forms – caused an estimated 2,000 to 8,000 episodes of bloodstream infection, resulting in the deaths of about 10 % of the patients. This severe package-integrity failure incident has triggered a heightened awareness of package integrity in the life science industry.
The key risks for contamination are by humidity, oxygen or microbiological ingress, which can impact the drug stability throughout the product life cycle. To prevent the risks of stability failure of highly moisture sensitive drugs (e.g. dry powder for inhalation) or the risk of biological ingress of sterile parenteral drugs, integrity tests with a high sensitivity are required.
The high risk in regards to pharmaceutical Container Closure Integrity Testing leads to a strictly regulated environment. Key authorities are the FDA (United States) and the EMA (Europe).
In 2008 the US FDA published a new guideline for the whole life science industry (pharmaceutical companies, veterinarian drugs and companies that manufacture sterile medical products) that obliges the sector to perform reliable physical measurement to ensure proper CCI.
Solutions for the pharmaceutical industry
In practice, the regulations of the FDA as well as the European Guideline for Good Manufacturing Practice with Annex 1 for the Manufacture of Sterile Medicinal Products are often interpreted quite broadly and without specific recommendations. The main obligation given to the manufacturers is that they must ensure “the container-closure system to maintain the integrity of its microbial barrier, and, hence, the sterility of a drug product throughout its shelf life” (US FDA).
Read more about this state of the art technology in the attached application report.
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