Aseptic Procedures & Sterility
Even though it is an FDA requirement that allergen extracts contain a preservative agent (e.g. phenol), it is essential to utilize aseptic techniques when preparing patient treament vials.
When working with allergen extracts it is important to use a dedicated workspace that is clean and free of clutter. It is also important to have a space that is quiet and away from distractions since the mixing and dilution of extracts requires careful attention.
Prior to beginning work with allergen extracts, you should always exercise proper aseptic techniques as a precaution against contaminants that may be present in your environment:
You should thoroughly wash your hands with a good antiseptic soap. The work surface and all vials should be wiped with an antimicrobial solution (e.g., 70% isopropyl alcohol) prior to use.
Disposable, pre-packaged, sterile syringes should be used for mixing or dilutions. To prevent cross-contamination you should use a separate, sterile syringe for each allergen extract vial that you are diluting or mixing.
For more information on the FDA’s preservative requirements, please see the section on Extract Formulations.
For more information see the following sections: