Gc Columns

Determining if a sterilizing grade filter is integral can be done via non-destructive integrity testing.

The test parameters for sterilizing grade membrane filters are based on correlating the test parameters with the LRV of the filter against a 107 CFU/cm2 challenge with Brevundimonas diminuta.

The filter cartridges can be tested by industry standard procedures as recommended in PDA Technical Report 26.

The test parameters are dependent on the surface tension of the wetting fluid to be used. Therefore, the parameters used in the procedures, listed below, assume the wetting fluid to be water. For test values using wetting fluids other than water the adjusted parameters have to be determined.

We can carry out and advise on the following integrity test procedures:

• Bubble Point
• Water intrusion test
• Forward Flow Diffusion
• Pressure Hold Test
• Wetting Procedures

• Reports will be provided after each  testing.

Rubber septum consists of a disk of rubber or similar material used to seal a vial or other device. It is installed along the inside of a cap, which is typically made of metal or plastic. A syringe needle pierces the rubber septum for the purpose of injection and, on withdrawal, the elasticity of the septum ensures that the hole reseals.

Rubber septa are most commonly used to seal medicinal vials containing either a liquid or freeze-dried solid (which is then liquefied in water or other substance). The medicine is drawn from the vial using a needle, then injected. Septa may also be used when a substance either needs to be injected into or pulled from a vial (or other device) then re-sealed.

Rubber septum design varies widely depending on the application. Medicinal vial septa are typically compression molded out of Silicone or Butyl rubber in multi-cavity molds within a high controlled manufacturing environment. Other septum types may include a chemical barrier layer, most commonly PTFE, or in extreme case, two barrier layers. These designs are most often punched from a sheet of rubber.

The quality of the barrier film and rubber are extremely important for many reasons. A poor quality septum may lead to improper re-sealing, skewed test results, or poor quality product. To minimize this, manufacturing inputs must be strictly controlled.

• Excellent toughness
• Temperature resistant
• Resistant to chemicals

• Superior absorbency
• Hydrophobic strength
• Free from contamination