USP 62 – Microbiological examination of non-sterile products: Tests for specified microorganisms [USP62]
Published: January 30th, 2019
Revised: March 24th, 2023
This is a product safety test specified by the United States Pharmacopeia Convention (USP) to evaluate the presence or absence of specified microorganisms. These tests are necessary for cosmetic and personal care products especially products that have high potential for use around the eyes, nose and mouth. Passage of these bioload challenges is required prior to the release of these products to market. It is not only important to determine the microbial burden of a product (See USP 61), it is also important to know what types of microbes are able to grow in a product. This test method determines whether your product will support of bacterial growth of potential pathogens such as:
- Staphylococcus aureus
- Pseudomonas aeruginosa
- Escherichia coli
- Salmonella enterica
- Candida albicans
- Clostridium sporogenes
- bile-tolerant Gram-negative bacteria
- fungi
Testing for this procedure is usually conducted for cohort of organisms, typically 3 or 4. As each organism has specific requirements related to incubation medium, temperature, and duration, we generally wait until all organisms in a cohort have been tested prior to reporting the results.
Laboratory code: USP62
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Prior to performing this test, a product should undergo suitability testing to ensure the non-interference of microbial inhibitor additives (in the same manner as that required prior to the performance of USP 61).
USP 61 – Microbial examination of non-sterile products: Microbial enumeration tests [USP61]
Published: January 30th, 2019
Revised: March 24th, 2023
This is a product safety assessment designed to evaluate the microbial content of non-sterile products such as pharmaceuticals products, cosmetics and personal care. These tests can be performed on finished products, raw materials or environmental swabs. The USP 61 assessment contains two tests, microbial enumeration and a suitability test:
1. Microbial enumeration
The microbial enumeration test is a full quantitative analysis of a product to determine the Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) present in the sample.
TAMC – Total Aerobic Microbial Count
Samples are plated onto bacterial recovery media such as TSA, followed by 3-5 days of incubation, to recover colonies of organisms that can grow aerobically at 30-35 C. Bacterial colonies, as well as fungal colonies that are recovered from this test are used in a final calculated plate count.
TYMC – Total Yeast and Mold Count
Samples are plated onto fungal recovery media (usually SDA), followed by 5-7 days of incubation, to target fungal colonies (yeasts and molds) that can grow aerobically at ambient temperatures (20-25 C). Fungal colonies as well as bacterial colonies that grow on the plates are used in a final calculated plate count. Unlike typical environmental monitoring test such as HPC, both bacterial and fungal microorganisms are counted. To determine total bacterial or fungal counts, two separate growth media are used and incubated at temperatures to selectively favour the growth of one type of organism over the other. It is only when these tests are used in combination that we can determine the pass or fail criteria for your product.
2. Suitability Test
This test is a preliminary step required to determine whether product is suitable for USP 61. Since pharmaceuticals products, cosmetics and personal care may contain inhibitors that will negatively bias the results of the test. This test requires bacteria to be spiked with the product in question and then subsequently recovered without being inhibited.
Laboratory code: USP61
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USP 797 – Pharmaceutical compounding: Sterile preparations [USP797]
Published: January 30th, 2019
Revised: March 24th, 2023
What is USP 797?
USP Chapter 797, Pharmaceutical Compounding: Sterile Preparations, outlines the standards for compounding sterile drug preparations in all pharmacy settings including those in, hospitals, retail settings, and long-term care facilities as well as other environments such as chemotherapy units, hospital nursing stations, and operating rooms. This standard is specifically designed to prevent patient harm from microbial contamination (non-sterility) and excessive bacterial endotoxins originating from the compounding facility. Therefore, the greatest level of control over manufacturing must be proven.
To whom do USP 797 standards apply?
USP 797 applies to everyone involved in sterile compounding such as the pharmacists, nurses, physicians and pharmacy technicians. Individuals involved in compounding sterile preparations must demonstrate competency in:
- Antiseptic hand washing and disinfection of nonsterile compounding surfaces
- Use of appropriate protective garb, such as gloves, gowns and masks
- Proper aseptic handling of products, sterilization of high risk compounding sterile products
How to comply with USP 797 Standards and Requirements
To comply with USP 797, pharmacies need policies and procedures that cover specific situations that arise during compounding. Areas that should be addressed in policy include verification of accuracy and sterilization and environmental quality and control. These conditions can be met by undergoing routine media fill and glove tip testing.
Media Fill Challenge Testing
This method is used to evaluate the quality of the aseptic skill of the compounding personnel using sterile fluid bacterial culture media-fill verification. The media filled containers (either TSB filled glass vials or TSB filled IV bags to simulate the appropriate compounding procedures used in your facility) are incubated for a minimum of 14 days at specific incubation temperature ranges. Following incubation, samples are assessed for visible turbidity (bacterial growth). Failure is indicated by visible turbidity in the medium on or before 14 days.
Glove Tip Testing
The careful cleansing of hands and correct donning of PPE (personal protective equipment) by compounding personnel constitute the first major step in preventing microbial contamination in compounding sterile preparations. Cells are normally shed from the human body and those skin particles are laden with microorganisms thus posing an increased risk of microbial contamination. This method is used to assess the ability of the compounding personnel in proper hand hygiene and gowning techniques. After completing proper gowning procedures, fingertip and thumb samples (from both their left and right hand) are lightly pressed into TSA plates (separate plates for each hand). These plates are then incubated at 30-35 C for 2 days, and 20-25 C for 5 days. Following incubation, analysis includes enumeration of bacterial colony forming units (CFU). Failure is indicated by the presence of 1 CFU or greater.
Please contact us for more details regarding USP 797 services and pricing.
Laboratory code: USP797
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Mérule pleureus analyse (ACP) [SLDNA]
Published: January 30th, 2019
Revised: March 24th, 2023
Mérule pleureus (autrement connu sous le nom de champignon pourriture sèche brune) peut causer des dommages irréversibles si rien n’est fait. Les dommages causés par mérule pleureus sont bien visibles et faciles à reconnaître car ils jaunissent souvent le bois infecté, lui donnant une texture friable et sèche. Cependant, au moment où ces symptômes sont visibles, le champignon est peut-être déjà à un stade avancé de décomposition. Il est capable de parcourir plusieurs mètres à travers des matériaux sans éléments nutritifs tels que le béton et la brique loin de la source d’humidité originale.
En réponse au besoin d’une méthode de détection précoce rapide pour mérule pleureus, Sporometrics a développé une méthode basée sur la ACP pour dépister le champignon pourriture sèche dans le bois. Si l’on soupçonne que la pourriture sèche se développe sur votre matériau de construction, envoyez-nous le matériau en question et nous pourrons vous apporter une tranquillité d’esprit.
Types d’échantillons à envoyer
- Échantillons en vrac du bois suspect
- Échantillons en vrac du champignon suspect
- Échantillons en vrac de sol
Code laboratoire: SLDNA
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Sporometrics receives Drug Establishment Licence
Published: January 30th, 2019
Revised: March 30th, 2020
In 2017, Sporometrics was issued a Drug Establishment License (DEL) by Health Canada, in accordance to the Food and Drugs Act and Regulations (Division 1). The license enables us to test pharmaceutical products including hard surface disinfectants and hand sanitizers. Health Canada conducts periodic inspections of our facility and operations to ensure our adherence with Good Manufacturing Practices (GMP).
