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USP 62

Published: January 30th, 2019

Revised: January 30th, 2019

Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms, 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.

These bioload challenges are often critical to the release of such products to market. It is not only important to determine how much microbial contaminants are in your product if any (See USP 61 ), it is also important to know what type of microbe can be found growing in your product.

This test method determines whether your product will support of bacterial growth of potential pathogens such as:

Staphylococcus aereus
Pseudomonas aeruginosa
Escherichia coli
Salmonella enterica
Candidia albicans
Clostridium sporogenes

bile-tolerant gram negative bacteria
Fungal organisms

Prior to performing testing, the product should undergo suitability testing in the same fashion as USP 61 .

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USP 61

Published: January 30th, 2019

Revised: January 30th, 2019

Microbial Examination of Nonsterile products: Microbial Enumeration Tests

USP Chapter 61 Microbial Examination of Nonsterile products: Microbial Enumeration Tests is a product safety test designed to evaluate the microbial content of nonsterile 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> 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 degrees 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 degrees 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.

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USP 797

Published: January 30th, 2019

Revised: January 30th, 2019

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 degrees C for a period of 48 to 72 hours. Following incubation, analysis includes enumeration of bacterial colony forming units (CFU). Failure is indicated by the presence of 1 CFU.

Please contact us for more details regarding USP 797 services and pricing.

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Mérule pleureus analyse PCR NOUVEAU! [SLDNA]

Published: January 30th, 2019

Revised: January 30th, 2019

Ne laissez pas la pourriture du bois se répandre chez vous!

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 PCR 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

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Sporometrics receives Drug Establishment Licence

Published: January 30th, 2019

Revised: January 30th, 2019

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 conduct testing on pharmaceutical products. As a license holder, Health Canada conducts periodic inspections of our facility and operations to ensure our adherence with Good Manufacturing Practices (GMP).

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