Container Closure Integrity Workshop
Our Quality Assurance Manager attended the Parenteral Drug Association Conference on 'Parenterals' held in Munich, Germany, 4-7 November 2014.
ams Laboratories attended the conference and a two-day workshop on 'Container Closure Integrity' in order to confirm that the quality of our Seal Integrity Testing exceeds both industry & regulatory expectations while staying up-to date with emerging technologies and trends.
The conference covered a broad spectrum of issues currently relevant to the sterile manufacturing community. Some of the many issues covered by the conference included:
ams Laboratories attended the conference and a two-day workshop on 'Container Closure Integrity' in order to confirm that the quality of our Seal Integrity Testing exceeds both industry & regulatory expectations while staying up-to date with emerging technologies and trends.
The conference covered a broad spectrum of issues currently relevant to the sterile manufacturing community. Some of the many issues covered by the conference included:
- New Manufacturing Technologies
- One Isolator for different filling machines and all packaging formats
- Emerging gloveless robotic technologies for cytotoxic drugs.
- Surface Sterilization
- Using H2O2, Vaporized H2O2, NO2 and ClO2.
- Quality Metrics and statistical process control in sterile manufacturing,
- Regulatory Inspection Trends,
- The proposed revision to USP <1207> 'Sterile Product - Package Integrity Evaluation".
Of particular interest was the workshop he attended on 'Container Closure Integrity' or 'Seal Integrity' testing, held immediately after the conference. This workshop covered in detail the regulations, theory and various test methods currently available to industry.
Manufacturers must confirm Container Closure Integrity for a number of reasons depending the product. For example, package integrity is not solely defined as the absence of microbial or liquid ingress for all products. It is important to remember that a package which is considered integral for one product may not be integral for other products.
The workshop addressed the different technologies available and importantly, the selection of the most appropriate both for in-line testing and QC release testing. For example, the methods listed below have varying sensitivities and no one method suits all products.
Manufacturers must confirm Container Closure Integrity for a number of reasons depending the product. For example, package integrity is not solely defined as the absence of microbial or liquid ingress for all products. It is important to remember that a package which is considered integral for one product may not be integral for other products.
The workshop addressed the different technologies available and importantly, the selection of the most appropriate both for in-line testing and QC release testing. For example, the methods listed below have varying sensitivities and no one method suits all products.
- Electrical conductivity and capacitance testing (aka High Voltage Leak Detection),
- Vacuum decay
- Laser based gas headspace analysis
- Mass extraction (aka mass flow test)
- Pressure decay
- Tracer gas detection
- Bubble emission test
- Microbial ingress test
- Tracer liquid test
Also covered were a number of Seal Quality Test methods including package seal strength test and residual seal forces.
ams Laboratories is now looking to expand the testing offered for Container Closure integrity and is, as always, available to offer consultation on selecting and qualifying the most appropriate test for your products.
Contact us now to find out more.
ams Laboratories is now looking to expand the testing offered for Container Closure integrity and is, as always, available to offer consultation on selecting and qualifying the most appropriate test for your products.
Contact us now to find out more.