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 excellent quality and performance. We strive to exceed our customers’ expectations and encourage continuous feedback. The consumables are manufactured in accordance with ISO 9001.
Our product lots are traceable down to the raw materials used and date of production.
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 if they have not exceeded the expiry date. Sterile products are compliant with ISO 111371¦2 or ISO 111353, and 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 manufacture of these products are free of
ingredients of animal origin, and are therefore deemed to be free of TSE/BSE-causing agents.
Ribonucleases/deoxyribonucleases (RNases/DNases)1¦2: These products are regularly tested for DNases and RNases, 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: These products are tested to qualify that all materials use USP and/or comply with 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