From Ready-go-Sterilize to Ready-to-Use: Validation Protocol for Sterile Plungers for Pre-filled Syringes

Francois Dessus

Stelmi S.A.
Le Raspail, Paris Nord II, 22, avenue des Nations, BP 59415 Villepinte, FR 95944 Roissy CDG Cedex, France
Tel:  +33 1 4863 5656  Fax: +33 1 4863 5699
Email: fdessus@stelmi.com

Biography

François DESSUS followed a scientific education at the University of Paris XI in Orsay finalised by a MSc in Material analysis for pharmaceutical use obtained in 1999 in the School of Pharmacy of Châtenay-Malabry.

After a one year transition period for military service, he integrates in 2001 Airsec – Group Süd-Chemie in the Research and Development service. He is expert in materials in charge of development of new formulations and responsible of the analytical laboratory. Current 2006 he joins Stelmi – Groupe Rumpler Technologies as Technical Director Assistant.

Biography

Since 1964, STELMI has been dedicated to the research and development of elastomeric rubber components of unsurpassed quality and cleanliness for the pharmaceutical industry.
Innovative R&D, coupled with ultra modern production techniques, enable STELMI to offer more pure and inert rubber formulations and outstanding washing processes, specifically adapted to each therapeutic class of parenterals.
STELMI specializes in the manufacture of:

• pre-filled syringe components (plungers, flexible and rigid needle shields, tip caps),
• stoppers for infusion, antibiotic, lyophilization, and diagnostic use that are compliant with all Pharmacopoeias.

Stelmi’s policy of constant innovation has made STELMI the specialist of “Ready-to-Sterilize” UltraClean stoppers, which exceed the drug industry demand for cleanliness, efficiency and compliance.

Abstract

Supplying “ready-to-use” primary packaging materials is the logical next step resulting from the supply of “ready-to-sterilise” components. In the case of pre-filled syringes, the syringe is sterilised with ethylene oxide after assembly with the needle shield or the tip cap. The syringe plunger itself is sterilised with gamma irradiation.

Ionising radiation has the advantage of sterilising the syringe plungers while they remain in their packaging. Possible risks of contamination are therefore limited to handling when transferring the materials to the sterile zone.
ISO regulation 11 137 can be utilised to perform the validation of the sterilisation procedure with gamma irradiation. This validation procedure has four main steps:
-       Determining the maximum irradiation dose
         tolerated by the product
-       Determining the sterilisation dose
-       Determining the irradiation dose received in
        each point of the batch to be sterilised (dose
        mapping)
-       Determining the expiry date.

Gamma sterilisation, which is easy to validate, is an excellent alternative to steam sterilisation for ready-to-use primary packaging articles and provides the pharmaceutical laboratories with all the necessary safety precautions. The issue of responsibility may be settled within a contractual context, where the key points to consider are the validation procedure, the validation files as well as the data, which led to the product being released.