VIAPURE® Statement of Quality
For GRIPTIPS®, CLEAR ADVANTAGE® reservoirs, PIPETBOY/VACUSIP filters and INTEGRA serological pipets
Our commitment to customers
INTEGRA consumables are produced from virgin materials using precise and consistent manufacturing techniques that ensure quality and excellent performance. We strive to exceed our customers’ expectations and encourage continuous feedback. The consumables are manufactured in accordance to ISO 9001.
Our product lots are traceable down to the corresponding raw materials used and date produced.
Our manufacturing process incorporates consistent in-process inspection throughout all phases of fabrication and assembly. All consumables are produced in a cleanroom setting to ensure purity and cleanliness. INTEGRA consumables produced under these strict conditions are contaminant free and consistent from lot-to-lot.
Sterility1¦2¦3: These products are manufactured, packaged and sterilized under controlled conditions and are considered sterile until opened and not having exceeded the expiry date. Sterile products have been released compliant with ISO 11137. The products meet a minimum requirement of 10-6 SAL (Sterility Assurance Level).
Pyrogen testing1: These products are regularly tested for endotoxins. Technicians certified to USP/FDA guidelines for medical devices perform the Limulus amoebocyte lysate (LAL) test according to USP 31 (United States Pharmacopeia) guidelines using the LAL gel clot procedure. The endotoxin acceptance level is <0.06 EU/ml.
PCR inhibitors1: These products are regularly
tested for PCR-inhibiting contaminants.
TSE/BSE statement1¦2¦3: The raw materials used in
the manufacturing of these products are free of
ingredients of animal origin and are therefore
deemed to be free of TSE/BSE-causing agents.
Ribonuclease (RNase) / Deoxyribonuclease (DNase)1¦2: These products are regularly tested for DNase and RNase and are free of any detectable DNA or RNA degradation.
Human DNA1¦2: These products are regularly tested for detectable genomic DNA.
Cytotoxicity testing2¦3: The test is conducted to qualify that all materials use USP and / or ISO 10993 standards for cytotoxicity and have been
shown to be non-toxic.
Graduation accuracy 2: Random samples of products with graduation markings are taken from each lot to ensure that the markings comply with our specification of ±2% at full scale.
1: applies to GRIPTIPS and CLEAR ADVANTAGE reservoirs
2: applies to INTEGRA serological pipets
3: applies to PIPETBOY/VACUSIP filters