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PAMA swab supply chain
PAMA Manufacturing and Sterilization has partnered with HP Canada and its consortium of 11 small businesses across Canada, which specialize in 3D printing and digital manufacturing, to support national requirements for personal protective equipment ( PPE) and COVID-19 testing.
3DP swabs have passed the clinical trials sanctioned by Health Canada. In the meantime, HP and its partners, including PAMA, have worked with other countries outside of Canada, such as the United States, Belgium, France, Norway and Spain as well as with organizations well known, such as the US military, for delivering millions of 3DP swabs.
These swabs have received regulatory approval from Health Canada (IO # 314006).
PAMA aims to support our country's COVID-19 testing requirements by producing up to 100 million nasopharyngeal swabs per year using HP's 3D printing technology (3DP). Swabs can be packaged individually or as part of a kit with transport media (PBS or VTM).
PAMA will lead its own swab supply chain and be responsible for the final efforts: sterilization, packaging, quality control and delivery.
Conclusion of the clinical study:
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RT-PCR Diagnostic Test Performance Agreement: The actual positive percent agreement is 93.90% .
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Ability to take a sample (RNase P): Swabs are similar in their ability to take a sample.
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User-friendliness: The nasopharyngeal swabs (SWB-0007) manufactured by PAMA are comparable to other swabs available in the market, in terms of user characteristics, ability to collect a sample and agreement of test results.
Consulting and training
We offer a consultation and training service on request. This service is offered for companies who are new to the market and who need support at the regulatory level and at the level of medical market standards.
More specifically, we are able to support you on the following points:
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Development of sterilization cycles
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Validation of sterilization cycles (in accordance with ISO 11135)
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Performing routine sterilization
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Health Canada medical device establishment licenses.
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ISO 14644-1: 2015 Class 7 - Cleanrooms and associated controlled environments - Part 1: Classification of particulate air cleanliness.
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ISO 13485: 2016 Medical devices - Quality management systems - Requirements for regulatory purposes.
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ISO 11135: 2014 - Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
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ISO 14971: 2019 Application of risk management to medical devices
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DEL (Drug Establishment Licenses)
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21 CFR Part 820 - Quality system regulation.