We perform Functional / Performance, Biological & Chemical testing of all products as per Pharmacopeias, ISO & ASTM methods. As a course of quality assurance for method improvements we also perform method development, method validation, process optimization & process validation.
Good Laboratory Practices
Laboratory Practices
We maintain Good Laboratory Practices at all level of below testing’s
Testing on Catheters, Tubing’s, Bag’s & Bottle’s
- Breaking force & connection fastness test
- Leakage & burst test (air & water)
- Flow rate test
Stability Study
- Accelerated or real time ageing of sterile barrier system
- Accelerated or real time ageing of medical devices
Biocompatibility Study Implementation
- Acute Systemic Toxicity
- Cytotoxicity
- In vitro Biological Reactivity
- Intracutaneous Irritation
- Sensitization
- Haemocompatibility
Testing Solution for Medical Packaging
- Medical film & paper tear & pin hole test
- Blister pouch peel off/seal strength test
- Blister burst & leakage test
Chemical Testing
- Acidity or Alkalinity
- Metal Ions (barium, chromium, copper, lead, and cadmium)
- Residue on Evaporation
- Resistance to Corrosion
- Ultraviolet Absorbance
- Acid Value
- Saponification Value
- Extractable Colour Test
- Ethylene Oxide Residue
- Moisture Content (Karl Fischer -Coulometric)
Syringe Testing
- Syringe plunger actuation force test
- Leakage test
Biological Testing
- Sterility test
- Bacterial Endotoxin Test
- Biological Indicator Test
Needle Testing
- Needle sharpness test
- Needle penetration test
- Needle stiffness test
- Needle-hub bond strength test
- Needle bending/resistance to breakage test
- Needle tip inspection test
- Suture needle ductility & elasticity test
Small Bore Connectors Testing
- Gauging test
- Unscrewing torque
- Separation force
- Stress cracking
- Resistance to overriding
- Ease of Assembly