TWIRL’EM® Sterile Sampling Bags: How are they Sterilised?
All bags are made of Virgin polyethylene manufactured in accordance with FDA (Food and Drug Administration) specifications: tube is sterile extruded; resins used are biologically inert. Product should not be used at temperatures greater than 82oC (180oF), tolerances: ± 10% on mil. thickness, ±1/8” on width and length.
Sterility is assured due to extrusion temperatures exceeding 220oC which will eliminate any present bacteria. During manufacturing all bags are sealed at both top and bottom in a continuous format before being cut into individual bags. This method assures that the bag’s interior will never come in contact with its surroundings. Only once the bag is opened by tearing along the perforated line is the bag’s interior susceptible to possible contamination from its present environment.
To further document this process, random lot samples are sent to an independent laboratory for analysis and submitted to the following tests: 1) Total aerobic bacteria detection. 2) Total anaerobic bacteria detection 3) Yeast detection 4) Mould detection 5) Salmonella CFIA (Canadian Food Inspection Agency) detection and 6) Listeria monocytogenes detection (6 days). Only once testing is complete and results confirm a sterile environment is the lot of material released for processing. Follow-up spot tests are also performed to further validate this process.
Lot specific certificates are available from Camlab.