Medzus | Combination Products Development & Testing
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Medzus Laboratories specializes in

Combination product testing for all types of applications, and can provide comprehensive testing services to support your regulatory submission, as well as design verification, method feasibility and validation, and routine analysis services.

Medzus Laboratories is able to provide

Design validation studies for the pens and needles to all parts of the standard. Medzus Laboratories will gladly develop a customized comprehensive combination product testing program to meet your company's regulatory requirements. An example of an all-encompassing combination product project is as follows:

The 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

Method Feasibility and Validation for Functional (Needle Shield Removal Force, Breakloose and Glideability, & Dose Accuracy) and CCI Testing

Plunger Movement Study

Simulated Distribution for Syringes in Shippers, with freedom from defect testing posttest

Functional and CCI Testing post Distribution Testing (T=0)

Real Time and Accelerated Aging

Additional Functional and CCI Testing at T=3, 6, 12, and 24 for Real Time and Accelerated Aging, as well as freedom from defect testing at each time point.

Examples of Drug-Device Combination Products

Prefilled Drug Delivery System

Prefilled Syringes

Prefilled Auto Injectors

Prefilled Pen Injectors

Prefilled on Body Delivery System

Dry Powder Inhalers

Prefilled Nasal Sprayers

Transdermal Patches

Oral Vaccine Delivery Device

Medicated Devices

Drug Coated Stents

Drug Coated Catheters

Drug Coated Pacemakers Leads

Antimicrobial Surgical Scrubs

Antimicrobial Wound Dressing

Antimicrobial Sutures

Drug Impregnated Surgical Mesh

Antibiotic Bone Cement etc.

ISO 20072
Dry Powder Inhalers & Metered Dose Inhalers Testing

Two separate international standards, ISO 20072:2009 and ISO 27427:2010, have recently been published that relate to the development and performance testing of oral inhaled products (OIPs).

The scope of ISO 20072 encompasses all OIP forms except nebulizing systems, whereas ISO 27427 was developed specifically for this class of OIP.

Bench Testing

Break loose and extrusion forces

Burst resistance

Break resistance

Closure system forces and torques

Connectivity with fluid path connectors

Residual volume

Needle penetration force

Needle pull-out force

Anti-needle-stick requirement

Visual Inspection

Needle Cap Forces

Dose Accuracy Test

Air Transport Plunger Movement

CCIT Integrity Test

Priming Volume

Injection Forces

Leak Test Under Compression

Cytotoxicity

Sensitization

Irritation/Intracutaneous Reactivity

Acute Systemic Toxicity

Genotoxicity

Implantation

Haemocompatibility

Freedom from defects

Proper assembly of replacement needles and cartridges

Accuracy of delivered dose

Extractables or Leachables

Extreme operating environments

Extreme storage environments

Extreme conditions of use

Packaging

Shipping conditions