Ensuring the Safety and Efficacy of Sterile Products
Accugen Laboratories provides essential sterility testing services to ensure that pharmaceuticals, medical devices, and other products meet strict microbial contamination standards. Our state-of-the-art facilities and adherence to regulatory guidelines guarantee that your products are safe for consumer use and fully compliant.
Advanced Sterility Assurance Through Strict Testing Protocols
What is Sterility Testing?
Sterility testing is crucial for determining if a product is free from viable microorganisms. It's a mandatory requirement for any product claiming to be sterile, including medical devices, pharmaceuticals, and some biotech products.
Regulatory Requirements:
Our testing services comply with all relevant standards, including USP <71> Sterility Tests, ISO 11737, and other regulatory requirements to ensure that your products meet all legal and safety criteria.
Testing Techniques:
We utilize both traditional culture methods and advanced rapid sterility testing techniques to provide accurate results. This includes membrane filtration, direct inoculation, and automated detection methods.
Industries Served:
Sterility testing is essential for industries where product sterility is a critical safety factor, such as pharmaceuticals, medical devices, and biotechnological products.
Quality Assurance and Control:
Our rigorous QA/QC procedures ensure the integrity of the testing process and the reliability of the results, providing you with confidence in your product’s sterility.
Custom Testing Solutions:
We recognize that different products may have unique testing needs, so we offer customized sterility testing protocols tailored to specific product requirements and regulatory standards.
Rapid Turnaround Time:
Understanding the importance of speed to market, we provide rapid turnaround options for sterility testing that meet your development and production schedules without compromising on quality or compliance.
Sterility Testing FAQs
Dive into our frequently asked questions about sterility testing at Accugen Laboratories. Learn more about how we ensure the sterility of your products and navigate the complexities of regulatory compliance.
Sterility testing is vital to prevent microbial contamination which can lead to infections, product recalls, and severe health risks to patients.
We follow the United States Pharmacopeia (USP) <71>, ISO 11737, and other applicable standards to ensure comprehensive compliance and safety.
For products sensitive to sterility testing methods, we use non-destructive techniques and ensure that the integrity of the product is maintained throughout the testing process.
Yes, we can develop and validate new sterility testing methods that are customized to your specific product needs and regulatory requirements.
Turnaround times can vary depending on the testing method and product type, but we strive to provide results as quickly as possible while ensuring accuracy and compliance.
Contact us with your project details, and we will guide you through the process, including sample submission, testing protocols, and expected timelines.
"Great lab to work with. Very accommodating and professional. Thanks you guys."
Larry Schrimpf
Begin Your Journey to Compliance and Safety
Accugen Laboratories is dedicated to providing you with comprehensive testing solutions tailored to your specific needs. By filling out the form, you take the first step towards ensuring your products are safe, compliant, and ready for consumers.
Our team is eager to assist you with expert advice, respond to your queries, and guide you through our testing processes. Submit your details today, and let us help you achieve excellence in product safety and regulatory adherence.