Phase 1: Design Validation Testing
This is the first stage of new product testing. During this stage, the design, construction, and integrity of the product are all rigorously tested to verify all parts are up to our specifications. All parts of this design validation testing must be satisfied before any final product production can begin.
Here’s what we test:
- Function test: Bag assemblies are subject to multiple function tests. This consists of docking and undocking multiple bags to the Alpha Port.
- Reliability test: The function test is repeated 10 times each to ensure reliable usage.
- Product use test: Bags are loaded with components and filled to 10 kg (22 lb), docked to Alpha Port, and emptied.
- Autoclave cycle: These same samples are then sent through an autoclave cycle (121° C) to verify the bag stays intact during this sterilization process.
- Destructive ammonia leak test: This process checks three areas of the bag to verify leak-tightness. The seal, interface of the bag to flange, and Alpha-Beta seal connections are all inspected after the ammonia testing process has been completed. A successful test is indicated by a lack of visible discoloring around any of these areas.
Phase 2: Ongoing Lot Testing
During this stage of product manufacturing, each lot is subject to validation testing to ensure every run meets our initial validation test specifications.
Here’s what we test in every lot:
- Particulate and endotoxin test: Samples of each run go to an independent lab for particulate and endotoxin testing and must meet our specifications for each. (See spec sheet here)
- Function and Leak tests: This step allows us to verify functionality (function and reliability test steps from above), and leak-tightness with ammonia testing.
This is all part of our process to guarantee high-quality products always reach our customers. If you have any questions about this process or CRL Single-Use Beta Bags, please contact us or view the Single-Use Beta Bags product page for more information.