Functionality Testing

Functional Tests are described and regulated by the following guidelines:

• USP, Chapter <381> - "Elastomeric Components in Injectable Pharmaceutical Product Packaging/Delivery Systems"
• USP, Chapter <382> - "Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems" (To be official on 1st December 2025)
• EP, Chapter 3.2.9 - "Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders and for Freeze-Dried Powders"
• ISO 11040 - "Prefilled Syringes"
• ISO 11608 - "Needle-Based Injection Systems for Medical Use - Requirements and Test Methods"

All our testing services fully comply with these guidelines.

The packaging systems which are subjected to functionality testing belongs to the following categories:

Vial and bottle systems:
Vial and bottle packaging/delivery systems have elastomeric closures fitted and compressed onto the container flange opening, mechanically held in place by a seal component.

Prefilled syringe systems:
Packaging/delivery system provided to the end user prefilled and ready for dosage form administration. A prefilled syringe is sealed usually with elastomeric components

Single-use syringe systems:
This category includes syringes for single use intended for transfer/delivery of specific pharmaceutical products. They are not provided by the drug product applicant in prefilled condition, and therefore, must be filled prior to administration with a drug product from another packaging/delivery system.

Cartridge systems:
Cartridge systems are sealed with two elastomeric components. One is a septum compressed onto the cartridge flange opening, mechanically held in place by a seal (also called a cap). The other elastomeric component is a plunger fitted inside the cartridge barrel that expels the contents of the cartridge.

These testing methods can be applied as described in the pharmacopoeias, without the need for any preliminary evaluation. They are dedicated to the elastomeric components of CCS, such as rubber stoppers in vials and cartridges. Following the analytical purposes of the most common standard functionality testing methods:

Fragmentation
To verify that the closure does not release fragments into the administrable solution upon being pierced.

Penetration Force:
To verify that the force required to pierce the closure does not exceed the recommended value and the product is readily accessible to the end user.

Self-sealing:
To verify that the closure seals completely after each needle penetration, preventing the escape of the contents and the ingress of external contaminants.

Deliverable Volume/Dose Accuracy:
To verify that the injection system is able to deliver the required or labelled content volume/drug dosage under normal usage conditions.

These testing methods cannot be applied indiscriminately to any item, but require a preliminary assessment on the instrumental parameters and equipment to use.

A general approach should be followed to develop a suitable test method and establish meaningful quantitative acceptance criteria that best represent the demands of the finished product packaging/delivery system.

Following the purposes of the most common customizable testing methods:

Injectability (Plunger Break-loose Force, Gliding Force):
To verify that the force required to initiate the movement of the plunger (Plunger Break-loose Force - PBF) and the force required to sustain the movement of the plunger to expel the contents of the syringe or cartridge (Extrusion Force - EF or Gliding Force - GF) do not exceed defined specifications, based on the needs of end-users.

Safety Device Activation Force:
The purpose of this test is to verify that the safety measures to shield the needle after injection (Activation Force - AF) does not exceed defined specification, based on the needs of end-users.

Safety Cap Removal Force:
To measure the axial force required to remove tip caps and needle shields used in injection systems.

Plunger Seal Integrity:
To verify that the plunger seal tightness for syringe and cartridge systems is satisfactory when forces simulating product delivery are applied and may induce leakage.