Promotion of Growth Test

Technical information

Utility

The European Pharmacopoeia and Good Manufacturing Practice require that before using a batch of microbiological culture medium, whether solid or liquid, its fertility and sterility must be demonstrated.

The growth promotion test is a quality control that verifies the ability of a new batch of culture medium to allow the growth of a predetermined selection of microorganisms recommended by the Pharmacopoeia (fertility).

Method

Following the European Pharmacopoeia, the following strains are used:

• Aerobic Bacteria:

  • Staphylococcus aureus ATCC 6538

  • Pseudomonas aeruginosa ATCC 9027

  • Bacillus subtilis ATCC 6633

  • Escherichia coli ATCC 8739

• Fungi:

  • Candida albicans ATCC 10231

  • Aspergillus brasiliensis ATCC 16404

• Anaerobic Bacteria:

  • Clostridium sporogenes ATCC 11437

Additional microorganisms such as Cutibacterium acnes or Bacillus cereus may be added if deemed necessary.

The strains are certified reference materials that must not have undergone more than 5 subcultures or reseeds before their use in the test. No more than 100 colony-forming units can be inoculated into the media.

Diagnostic Algorithm

If microbial growth is detected, the microorganism is identified using MALDI-TOF.

Results

The expected result is:

• A NEGATIVE result in the negative control (medium without inoculated microorganism)

• A POSITIVE result and the detection of the corresponding strains in the positive controls (medium with inoculated microorganism)

This expected result indicates that the growth promotion test is correct, the medium is fertile, and can be used. Any deviation from the expected result is out of specifications and must be investigated.

Precautions

A growth promotion test must be performed before using a microbiological culture medium.

Response Time

• 20 days

Specimen information

Sample: Medium to be verified

Tubes: BACT/ALERT vial, liquid medium or solid medium

Stability: Transport as soon as possible to the laboratory.

Transport instructions: Room temperature or refrigerated (according to manufacturer's instructions).

Reason for rejection: Unidentified sample, insufficient sample, etc.

Administrative information

BST Code: See Table 1

Old BST Code: See Table 1

Test Description: See Table 1

Synonyms: Growth Promotion Test, GPT.

Section: Microbiology

BST Rate: Check the updated rates here.

Profiles
Not applicable

Table 1: Summary Table of Tests

References

• Guide to the quality and safety of tissues and cells for human application. 5th edition EDQM, 2022

• Farmacopea Europea 11ena edició, 2023

• NCF: Guía de Normas de Correcta Fabricación de Medicamentos de Uso Humano y Veterinario. Anexo 1

• NCF Parte IV: Directrices sobre normas de correcta fabricación específicas para Medicamentos de Terapia Avanzada.