Medzus | Good Laboratory Practices
Open

Small Bore Connectors Testing

Gauging Test

Dimensional Analysis

Falling Drop Positive Pressure Liquid Leakage

Sub Atmospheric Pressure Air Leakage

Stress Cracking

Resistance To Separation From Axial Load

Resistance To Separation From Unscrewing

Resistance To Overriding

Combination Product Testing

ISO 11040-8 Prefilled Syringe Studies

Break Loose & Extrusion Forces

Burst Resistance

Break Resistance

Closure System Forces & Torques

Connectivity With Fluid Path Connectors

Residual Volume

Needle Penetration Force

Needle Pull-Out Force

Anti-Needle-Stick Requirement

ISO 11608

Medzus is able to provide design validation studies for the pens and needles to all parts of the standard. We have auto injector testing programmes for all types of pen; A, B1, B2, C and D1, D2. We also offer standard programmes for needle bond strength, flow rate, compatibility, etc.

Break Loose & Extrusion Forces

Burst Resistance

Break Resistance

Closure System Forces & Torques

Connectivity With Fluid Path Connectors

Residual Volume

Needle Penetration Force

Needle Pull-Out Force

Anti-Needle-Stick Requirement

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


Syringe Testing

Syringe Plunger Actuation Force Test

Leakage Test

Chemical Testing

Acidity or Alkalinity

Residue on Evaporation

Resistance to Corrosion

Ultraviolet Absorbance

Acid Value

Saponification Value

Extractable Color Test

Ethylene Oxide Residue

Moisture Content (Karl Fischer -Coulometric)

Metal Lons
(barium, chromium, copper, lead, & cadmium)

Biocompatibility Study
Implementation

Cytotoxicity

Skin Sensitization

Irritation/ Intracutaneous Reactivity

Acute Systemic Toxicity

Genotoxicity

Implantation

Haemocompatibility


Biological Testing

Sterility Test

Bacterial Endotoxin Test

Biological Indicator Test

Testing on Catheters,
Tubing's, Bag's, & Bottle's

Breaking Force & Connection Fastness Test

Leakage & Burst Test (Air & Water)

Flow Rate Test

Testing Solution
for Medical Packaging

Medical Film & Paper Tear & Pin Hole Test

Blister Pouch Peel off/seal Strength Test

Blister Burst & Leakage Test

Stability Study

Accelerated or real time ageing of sterile barrier system

Accelerated or real time ageing of medical devices