Manufacturing & Testing Service
Our medical device services start from product design & development to batch release; we specialize in productassembly, packaging, sterilization & testing. We use & apply various different techniques, machines & instruments for successful launching of your requirement with considering international harmonized standards. Also helps you to makes your idea workable for customized application.
1. Medical devices manufacturing services:
Our medical device manufacturing process services gives you complete solution for your product to be launched in market. We involved in the following segments of sourcing & implementation –
1.1 Product Assembly:
- Raw & semi-finished material selection & sourcing
- Product cutting (Mechanical or Laser Techniques)
- Catheter tipping (Open tip type)
- Forming (Close or Open type)
- Hole punching (Mechanical or High Frequency)
- Bonding (Adhesives or Heating)
- Welding (High Frequency & Ultrasonic)
- Sutures swaging & crimping (Absorbable & Non-Absorbable Sutures)
1.2 Packaging:
- Packing material selection & sourcing
- Medical grade pouch packaging
- Tyvek & medical grade blister packaging,
- Aluminum blister moisture proof packaging.
1.3 Sterilization:
- Ethylene oxide sterilizer installation & commissioning
- Sterilization validation
- Sterilizer calibration
- Protocol & report preparation
2. Medical device testing services:
We gives solution for functional & performance testing of various range of surgical medical devices as per FDA, CE, ASTM, and ISO guidelines. Our services help in test method development, method validation, process optimization & process validation. Also provide best solution for biocompatibility testing, chemical testing, stability testing & clinical evaluation of medical devices.
We specialize in calibration & testing services for all small bore connectors specified in ISO 80369-1 to 7 & 20. We are able to help for customized testing application to makes your idea workable.
2.1 Testing for Small Bore Connectors as per ISO 80369-20:
- Gauging test
- Unscrewing torque
- Separation force
- Stress cracking
- Resistance to overriding
- Ease of Assembly
2.2 Testing Solution for Needles:
- 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
- Needle hub connectors (luer) test
2.3 Testing Solution for Syringes:
- Syringe plunger actuation force test
- Leakage test
- Syringe luer test
2.4 Testing Solution for Catheters, Tubings, Bags & Bottles:
- Breaking force & connection fastness test
- Leakage & burst test (air & water)
- Flow rate test
2.5 Testing Solution for Medical Packaging:
- Medical film & paper tear & pin hole test
- Blister pouch peel off/seal strength test
- Blister burst & leakage test
2.6 Chemical Tests Implementation:
- Acidity or Alkalinity
- Metal Ions (barium, chromium, copper, lead, and cadmium)
- Residue on Evaporation
- Resistance to Corrosion
- Ultraviolet Absorption
- Acid Value
- Safonification Value
- Extractable Colour Test
- Ethylene Oxide Residue
- Moisture Content (Karl Fischer -Coulometric)
2.7 Biological Tests Implementation:
- Sterility test
- Bacterial endotoxin test
- Biological indicator test
2.8 Stability Study Tests Implementation:
- Accelerated or real time ageing of sterile barrier system
- Accelerated or real time ageing of medical devices
2.9 Surgical Medical Device Biocompatibility Tests Implementation:
- Cytotoxicity
- Sensitization
- In-Vitro Biological Reactivity
- Intracutaneous Irritation
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