Analytical testing and specifically microbiology testing of pharmaceutical and medical device products can be challenging for many manufacturers/distributors, particularly small to medium sized companies as they often do not have the expertise, space, understanding of the testing to be able to conduct testing accurately and to the regulatory requirements.
There are several reasons why you would choose to use a contract laboratory for your microbiology testing needs:
Microbiology is notoriously labour intensive, particularly when you add in the regulatory requirements of testing to the pharmacopoeias or USP chapters. There are often a significant number of quality checks, measures, calibrations, qualifications, validations and so on that must be conducted on a regular basis.
There is an initial and on-going outlay for the cost of equipment such as freezers, fridges, incubators, laminar flow cabinets, balances, pipettes and then the on-going cost of calibrating, maintaining, and replacing this equipment over time. Not to mention the downtime if you are reliant on single pieces of laboratory equipment.
It is often difficult to find experienced microbiologists and in many cases companies who manufacture do not have a microbiology subject matter expert or scientists capable of conducting the testing in-house. There is also the significant cost/time to train these individuals and ensure that they remain up to date with the latest methodology, understanding and regulatory requirements.
When conducting microbiological or analytical testing in general it is important to ensure that the testing conducted complies with the standards and regulations in the area in which you hope to operate, e.g. European pharmacopoeia, US pharmacopoeia, JP pharmacopoeia, ISO 10993 for medical devices etc.
These can often be tricky to interpret and put into practice in a compliant way. There is also a cost and a time burden of ensuring your quality management system is compliant with regular client and external inspections to these standards. Any company involved in this level of regulated testing, specifically to ISO, GMP/GLP standards must ensure they can maintain and continuously improve their practices and policies to stay compliant, which comes with a significant cost.
Scaling Up Analytical Testing
Often where manufacturers have some testing capability they can then struggle when their product or testing requirement scales up. This can be a further outlay of money and time for manufacturers for capital equipment, personnel, training, premises, cleaning, validation, calibrations, qualifications and so on.
It can often be difficult without significant investment to achieve a quick throughput at higher volumes of samples without significant investment.
Technologies/Techniques in Microbiology
It can be difficult for some manufacturers to stay on top of all the latest requirements in microbiological testing and the associated updates in regulatory requirements. These can have a direct impact on the types of testing recommended, techniques and technologies that are desirable and the level of checks, and support that are needed to conduct testing appropriately.
Contract laboratories solely focus on this niche testing and have a requirement to stay abreast of the latest trends and actively seek to improve their competitiveness and compliance level through developing novel methods, updating existing methods and investing in newer technology to improve their throughput and reliability of data.
When manufacturers have their own microbiology laboratories, they can often conduct some rudimentary testing and produce results. However, where they can stumble is not knowing how to interpret that information and what it means to their product, environment, processes and so on.
Having a laboratory where there are experts available with experience across multiple different industrial settings they can offer advice on sources of contamination, improvements in cleaning practices, methodology, identifications to higher levels of security and trending and tracking of microorganisms to understand what it means is key.
They can help you establish specifications for products, understand what is allowable or objectionable, and establish what testing is appropriate for the product you are testing. Often clients have products that are difficult to manipulate or extract the contents from, such as devices, inhalers, canisters, and poor aseptic practices can cause erroneous results which impact the ability of the product to be released.
Peace of Mind
Microbiology testing can seem often as an easy set of tests to conduct in-house for manufacturers but often it is cheaper, quicker, and more reliable to have a good contract laboratory to conduct the testing for you on a regular basis.
They can provide the right level of accuracy, reliability, compliance, and scalability to be able to achieve the often, pressing deadlines within the industry for batch release of products. It is important to check the laboratory you are using have the right credentials, quality systems, processes and policies in place and ensure you have quality technical and/or master service agreements and a good supplier qualification program for initial sourcing and on-going assurance that your testing is being conducted appropriately.
Having a laboratory that is investing heavily for the future in terms of new technologies, increased capacity, and personnel to grow with your company is of utmost importance for reliability of your results.
Checklist for Selecting the Right Contract Laboratory
- Accreditation and Compliance: Ensure the laboratory is accredited to relevant standards (e.g., ISO, GMP/GLP) and complies with the pharmacopoeias or USP chapters relevant to your region and product.
- Expertise and Specialisation: Verify that the laboratory specializes in microbiology testing and has a team of experienced microbiologists familiar with your product type.
- Equipment and Technology: Check if the laboratory possesses state-of-the-art equipment and technology suitable for your testing needs, including the ability to handle complex or unique product formats.
- Quality Management Systems: Confirm that the laboratory has robust quality management systems in place, with a history of passing client and external inspections.
- Scalability and Throughput: Assess the laboratory's capability to scale up testing in response to increased production volumes or evolving requirements without compromising turnaround time.
- Methodology and Innovation: Determine if the laboratory actively stays abreast of the latest testing methodologies and regulatory updates and invests in developing and improving testing methods.
- Interpretation and Consultation Expertise: Ensure that the laboratory not only provides testing services but also offers expert interpretation of results and consultancy on contamination sources, cleaning practices, and product specifications.
- Cost and Time Efficiency: Evaluate the cost-effectiveness of the laboratory's services and its ability to meet your deadlines, especially for batch release.
- Supplier approval/suitability: Perform supplier qualification and approval processes and on-going monitoring of your contract testing laboratory.
- Future Investment and Capacity Expansion: Consider the laboratory's commitment to future investments in technology and personnel, indicating their readiness to grow alongside your company.
Choose Wickham Micro for Premier Microbiology Testing
Expertise and Specialisation:
At Wickham Micro, our experienced team excels in microbiology testing and results interpretation, providing valuable insights for your product's quality and safety.
Advanced Facilities and Equipment:
With expert technology, we handle a diverse range of tests efficiently, ensuring precision and reliability in every analysis.
Compliance and Quality Assurance:
Accredited to GMP, GLP and FDA standards, we offer top-quality testing that meets rigorous regulatory requirements.
Customisable and Scalable Services:
Our flexible testing solutions cater to your specific needs, supporting your growth with scalable options that fit your company's size and demands.
Expert Consultation and Support:
Beyond testing, we offer guidance on regulatory compliance, contamination sources, and product specifications, ensuring your product's market success.
Dedicated Customer Service:
Our business support team and study managers are always ready to assist, ensuring a seamless and responsive experience for every client.
We constantly evolve our methods and technology, keeping you ahead in the fast-paced world of microbiology testing.