Lab standards

The stringent standards upon commercial allergy extract laboratories have been established, however none for private laboratories of physicians dispensing these extracts for therapy within Canada. We have, over the years, modified and updated our standards to the highest degree. 

Ideally, all laboratories should adhere to strict standards to ensure that top quality and safety of all products as follows:

1.       All extracts are prepared by a trained nurse, who is always gowned, capped, and masked while mixing.  Nurse always washes hands before and after mixing and wears gloves during mixing.

2.       Limited access to Lab clean room – Only one nurse, lab assistant and cleaners are granted access to the clean room.

3.       Doors in the clean room are locked at the end of the day, and overnight.

4.       All bottles and syringes are always sterilized with alcohol each time it is used. All syringes are discarded upon completion of extracts vails.

5.       The mixing room is air filtered and has positive pressure reading in relation to other rooms.  

6.       Surfaces of the mixing and packing table are thoroughly wiped before and after use.

7.       The room is carefully cleaned on a weekly basis by profession cleaners.

8.       All extracts are mixed in laminar hood flow units, which are inspected annually by professionals. We use HEPA (High-efficiency particulate air) filters, one of the most important elements of a cleanroom. They consist of a large, box shaped filter that removes airborne particles of specific sizes very efficiently.  

9.       We ensure that random samples of extracts are subjected to the sterility testing (one every 5 sets) for both aerobic and anaerobic growth with a minimum 7 day waiting period.  Only after 7 days the patient is contacted to start shots or items are sent out.

10.   Vial labeling incudes the patients name, extract number(s), and contents.  All extracts come with a schedule and refill forms, and indicative of safety and administrative procedures.

11.   Formulation and details on allergy extracts for each patient is stored electronically in Rosch EMR. Updated on an on-going basis as needed and backed up regularly.

12.   Refrigerators for storing extracts are monitored, and temperatures are recorded daily.  Daily temperature of 2 -8 degrees is kept (are required by Health Canada).

13.   Refrigerator #1 is used for storing allergy extracts. Refrigerator #2 is used for packaged items and completed extracts. Daily Temperature of 2 – 8 degrees.

14.   The humidity and temperature of the Laboratory is monitored daily.

15.   Standard Operations Procedures for Mixing in Laboratory and Administration is updated on an as-needed basis and reviewed annually.