Culture Media

Background

Imported culture media represents a significant biosecurity risk to Australia as many culture media products can be used in manufacture of biological components that will be used in Australian animals. If imported culture media is contaminated with disease agents it is possible that these disease agents will be carried through to the Australian animal.

AQIS conducts a rigorous assessment of all import permit applications for culture media. Applications for multiple products (or products catalogues) can be lengthy and costly as each product will undergo individual assessment.

Note: Occasionally AQIS receives applications for catalogues of culture media products that are all manufactured using a limited number of biological ingredients. Under these circumstances, rather than assessing each product individually, AQIS will assess each of the biological ingredients.   

In order to streamline the assessment process AQIS requests that applicants categorise each product into one of the following five categories:

1.   Pre-prepared solid media e.g. plates or slopes

2.   Selective or differential culture media strictly for in vitro use only. Media in this category will be diagnostic tools, highly selective media, or indicator media. This category does not apply to non-selective nutritive media and culture media with a potential for in vivo or field use or for tissue culture.   

3.   Culture media less than 20g or 20mL per individually packaged unit

4.   Less than 20g or 20mL of animal derived material per individually packaged unit

5.   Media in volumes greater than 20g or 20ml (where categories 1 or 2 do not apply) – Bulk culture media.

Providing the information in table format so it can be easily referenced will assist AQIS in the timeliness of the assessment. An example is given below:

As part of the assessment process AQIS requires supporting technical information to verify the categorisation of each product. The following is a guide to the information that is to be submitted:

1. Pre-prepared solid media e.g. plates or slopes

• Product information leaflet or reference to an online catalogue.

2. Selective or differential culture media

• Product information leaflet which describes the attributes/end use of the product.

N.B. AQIS will determine if there exists a potential for the product to be used as a non selective nutritive or tissue culture media. If this potential exists the product will be assessed according to the requirements of one of the other categories listed below.

3/4. Culture media less than 20g/ml per individually packaged unit or less than 20g/ml of animal derived material per individually packaged unit.

• Full ingredients list for the product (including percentages/weights of ingredients)
• Volume of any animal derived material
• Size of each individually packaged unit.

5. Media in volumes greater than 20g or 20ml (where criteria 1 or 2 do not apply) – Bulk culture media.

• Full ingredients list for the product
• Species and country of origin of all animal derived ingredients
• Tissue of origin of any bovine, ovine or caprine ingredients (e.g. skeletal muscle, casein)
• Manufacturing details of all animal derived ingredients including the times and temperatures of any heat treatments.

Government veterinary certification for bulk culture media

Imports of bulk culture media (category 5 above) must be accompanied by official government veterinary certification relating to the animal derived ingredients. There are two certification options for bulk culture media:

1. Standard permit, which requires official government certification with each consignment relating to the animal derived ingredients in each imported product

2. Permit which requires an official government endorsed manufacturer’s declaration with each consignment. To qualify for this permit condition, in addition to the product information above, the following documentation must be provided at the time of application:

A declaration from the Managing Director of the exporting company certifying that:

a. For the products containing animal materials, the company has complied with AQIS requirements concerning the animal species and country of origin and the treatment for the raw material used in the products

b. The Australian importing company will be notified of any changes in sourcing and/or processing of animal components and will seek AQIS approval prior to shipment to Australia

c. The manufacturer adheres to Good Manufacturing Practices (GMP) as administered by the relevant Government regulatory authorities in the country of manufacture, and continues to be certified under ISO9000 standards relating to quality systems.

This declaration must be endorsed by an official government veterinary officer.