Sterility testing is among the most critical components of pharmaceutical quality assurance. It ensures that the products that are meant for parenteral administration do not contain microorganisms.

With the evolution of pharmaceutical companies, there has been a noticeable transformation of the technologies and methodologies employed in the process of sterility testing.

Here’s everything you need to know about the evolution of sterility testing in pharmaceuticals.

Historical Context

The need for sterility testing and its history can be traced all the way back to the 19th century. It became evident that contamination could pose a threat on patient safety and simultaneously, aseptic techniques begin to take shape.

The very first formal guidelines for sterility testing were established in 1930s. These set of rules focused mainly on basic culturing techniques along with visual observation. However, these methodologies had a high percentage of false negatives as a result since they lacked the specificity and sensitivity.

With the passage of decades, the pharmaceutical company underwent an expansion and the complexity of drug formulations also increased. New modalities such as vaccines and injectable biologics further emphasized on the significance of thorough sterility testing. In addition to this, regulatory bodies imposed rigid guidelines for sterility testing which ultimately led to an increase in the requirement of advanced methods.

Traditional Methods of Sterility Testing

In the early times, sterility testing was mostly dominated by two methods namely agar plates and broth cultures. Samples extracted from the pharmaceutical products were then infused in a solid media or liquid broth. This was followed by incubation and growth was observed.

These methods accompanied a number of different limitations such as:

1- Increased time-consumption: Incubatory times were prolonged and ranged from a period of days to further weeks. This ultimately led to a deceased release of product.
2- Less sensitivity and specificity: Detection was mainly dependent on growth of microorganisms. This would cause a miss of fastidious organisms along with the microorganisms that couldn’t be cultured.

Regardless of these crucial limitations, these methods served as the core of sterility testing till the late 20th century.

Conventional sterility testing procedures involved the following:

• Direct Transfer Method: This method does what its name says. It directly inoculates a sterility medium with a sample from the product. It was commonly used for the liquid products.
• Membrane Filtration: This method simply involved filtration of a liquid sample through a membrane. This membrane had the ability to trap microorganisms. The filter was then placed on a growth medium for the purpose of growth.
• Bacterial and Fungal Cultures: Samples were inoculated on media such as soybean casein digest broth (SCBD), potato dextrose agar (PDA) and tryptic soy broth (TSB).

Transition to Modern Techniques

Sophisticated sterility testing methods emerged in the late 20th and early 21st century. Alternatives were explored as a result of advancements in technology and enhanced regulatory scrutiny.

Innovations in Testing Methods

1- Automated Systems: Automation in sterility testing has revolutionized workflows. Automated systems have the ability to inoculate media fast, observe and monitor incubations and identify microbial growth. This results in a significant decrease in output time.
2- Rapid Microbiological Methods (RMM): These encompass a lengthy list of techniques such as impedance measurements that provide results in a matter of hours. These methods have gained popularity over the years for not only giving instant results but for also being reliable.
3- Molecular Techniques: Polymerase Chain Reaction (PCR) along with Next-Generation Sequencing (NGS) have been established as effective and powerful tools used for the purpose of sterility testing. These methods are helpful in detecting pathogens all while providing insights in microbial diversity.

The Role of CMDC Labs

CMDC Labs have played a potent role in the field of sterility testing by offering a vast and diverse range of services that have roots deeply embedded with in the modern methodologies. The laboratory prioritizes quality by employing top-notch techniques so as to meet the requirements of the pharmaceuticals industry.

Services Offered by CMDC Labs

1- Method Development and Validation
The Lab is highly specialized in not only developing but also validating methods that are customized to specific products therefore ensuring compliance with the set of regulatory standards.
2- Comprehensive Sterility Testing
Sterility testing methods under the umbrella of CMDC utilize both, the classical traditional and innovative modern methods. This is done to provide the clients with flexible options so they can choose the most appropriate testing technique in accordance to their product.
3- Consultative Support: CMDC labs offer consultation services to their clients. This enables them to select and implement the best practices of sterility testing for their products. Moreover, the overall experience becomes much easier.
4- Environmental Monitoring; To product sterility, CMDC labs use a proactive approach. Environmental monitoring is rigorously done to make sure that the manufacturing environment is free from contaminants.