Pharmaceutical Leak Testing Applications Laboratory And Services
Pharmaceutical leak testing is a crucial process for ensuring the safety and sterility of medical and drug packaging, particularly in applications such as CCIT Test Method Validations, pilot production runs, and small-scale production runs. While pharmaceutical manufacturers may not have the resources to invest in leak testing equipment or trained personnel, inadequate testing can have serious consequences. In this article, we will discuss the leak testing services offered by Pfeiffer Vacuum and how they can help manufacturers meet regulatory requirements and ensure the safety of their products.
Leak Testing Services Offered
Pfeiffer Vacuum offers a range of pharmaceutical leak testing services, including CCIT Test Method Validations (TMV) consistent with regulator body SOP, non-destructive CCI testing of medical packaging using our micro-flow technology in compliance with ASTM, SAE, and USP specifications, and testing using helium mass spectrometers utilizing hard vacuum, accumulation, and sniffing modes. We also offer periodic calibration and support services of Pfeiffer Vacuum products either at our facility or on-site and CCIT specification development testing and consultation.
Regulatory Requirements
While particular tightness requirements or testing methods are not mandated for all medical packaging by regulatory bodies, they are increasingly requiring that adequate testing be performed to ensure the sterility of their contents and the safety of patients. The responsibility of establishing the adequacy of a testing method for a particular CCIT application falls on the manufacturer. We understand that this responsibility may seem burdensome and daunting, but we can help to make that responsibility seem less of a burden.
Basis for CCIT Specification Recommendations
The basis for CCIT specification recommendations include, but are not limited to, USP 1207, PDA Guidelines, ASTM specifications, small batch studies, test method validations, and extensive CCIT experience. Our team of experts can provide guidance and recommendations based on these specifications to ensure that manufacturers are meeting regulatory requirements.
Technological Ability
Pfeiffer Vacuum can employ the broadest range of leak testing technology, including micro-flow pressure and vacuum air leak testing, mass-extraction vacuum air leak testing, optical emission spectroscopy (AMI 1000), and helium mass spectrometers for MALL testing (ASM 2000). This breadth of technological ability ensures that Pfeiffer Vacuum can give the most unbiased recommendations regarding test methodology of any leak testing manufacturer.
Conclusion
Pharmaceutical leak testing is a critical component of ensuring the safety and sterility of medical and drug packaging, but it can be a complex and daunting process. Pfeiffer Vacuum’s pharmaceutical leak testing services can help manufacturers meet regulatory requirements and ensure the safety of their products. Our team of experts can provide guidance and recommendations based on regulatory specifications, and our broad range of leak testing technology ensures that we can give the most unbiased recommendations regarding test methodology. Contact us to learn more about our leak testing services and how we can help your organization meet its testing needs.
Pfeiffer Vacuum performs leak testing in our new application laboratory. Our leak testing team is certified by the American Society of Non-Destructive Testing (ASNT) in multiple leak testing methods. We strive to deliver the highest quality of services to our clients, including clear and accurate assessment results in accordance with our client’s and the applicable standard specifications. Our engineers and technicians are well trained, experienced, qualified, and driven to exceed your expectations.
Featuring:
- ASM 340 Helium / Hydrogen Leak Detector
- ASM 306 Helium / Hydrogen Leak Detector
- E2 Air / MicroFlow Leak Tester (Pressure & Vacuum)
- EPDQ Air / MicroFlow Leak Tester (Pressure & Vacuum)
- SpeedAir 3050 CCIT Leak Tester (USP1207 Certified)
- Custom Machining Equipment