Sterility Testing

All pharmaceutical products must be of high quality and widely safe in order to be used by medical professionals for patients. Otherwise, it may cause issues for the patients. In this, it is essential to ensure that sterile pharmaceutical products are compliant. Sterility testing can ensure this. According to the United States Pharmacopeia (USP) chapter<71>, sterility testing is a procedure used to determine whether a product is sterile or free from viable microorganisms. It is crucial for ensuring that products meet the necessary safety and quality standards, and to guarantee a safe application in patients. At Alfa Chemistry, we offer an exceptional sterility testing (USP<71>) service. Our experts employ stringent methods of testing and state-of-the-art technology to provide accurate outcomes. In addition, understanding the sensitive nature and needs of the pharmaceutical industry, we are committed to providing results in a timely and efficient manner.

When must sterility testing be performed?

The sterility testing procedure becomes essential in several scenarios.

• Firstly, the relevant regulations require that sterility testing is mandatory for all sterile products before release into the marketplace. The objective is to detect possible microbial contamination during the manufacturing process.
• Secondly, sterility testing is required in the context of validation operations of sterile products. This ensures that the sterilization process has been effectively executed and verifies the cleanliness of the production environment.
• Finally, it becomes crucial during stability studies, where products are monitored over time under specific storage conditions. Here, sterility testing helps to verify that the product remains free from microbial contamination over its projected shelf life.

Alfa Chemistry's sterility testing services

We strictly adhere to the standardized procedures of USP<71>to ensure the removal of false positives, ensuring the infallibility of our sterility testing results.

Our services are suited for a range of product types, including:

We employ two commonly used methods for sterility testing:

We follow a rigorous sterile testing process, and the details are shown below:

1. Alfa Chemistry's sterility testing process begins with a thorough examination of the product's nature and characteristics. Based on this, the appropriate testing method is selected.

2. In membrane filtration method, after sample preparation, the product is forced through a 0.45 micron pore-sized cellulose nitrate membrane filter that retains any potential microbial contamination. The membrane filter is then incubated on a nutrient medium at specific temperatures for not less than 14 days. For direct inoculation method, the sample is added to two types of nutrient media – one that promotes microbial growth and another for fungal growth. Both media are then incubated at specified temperatures for 14 days.

3. Upon completion, the test samples are checked for turbidity, which indicates microbial or fungal growth. If growth is observed, the sample is considered non-sterile, and specific actions are taken to rectify the contamination in the product.