Customized and Reliable Sterilization Processes

Neopharm offers comprehensive sterilization services for the pharmaceutical industry, including filter validation, integrity testing, compatibility studies, bacterial retention evaluation, and extractables & leachables assessment.

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Ensuring the safety and efficacy of parenteral drugs is of paramount importance, and our Filter Validation services address the unique requirements and challenges associated with these critical pharmaceutical products. 


Tailored Sterilization Processes

Our Filter Validation services go beyond standard solutions. With our extensive experience and in-depth knowledge of pharmaceutical requirements, we specialize in assessing the efficiency of any customized sterilization processes.

Compliant with Industry Regulations

We prioritize compliance with industry regulations, guidelines, and standards, giving you peace of mind that your filter validation is conducted in accordance with the highest quality and safety standards.

Accurate and Reliable Results 

We utilize advanced techniques combined with our Microbiology R&D team knowledge to deliver accurate and reliable validation results, enabling you to make informed decisions about the suitability and performance of your filtration process.

Comprehensive Services

  1. Filter Integrity Testing: We employ Bubble Point measurement to assess the integrity and performance of filters, ensuring their capability to remain efficient under your process conditions. 
  2. Compatibility Studies: Our experts evaluate the compatibility of filters with various drug formulations, identifying any potential interactions that may impact filter performance or compromise product quality.
  3. Bacterial Retention Evaluation: We conduct rigorous testing to determine the ability of filters to retain bacteria, preventing their passage into the final drug product and ensuring your drug product sterility.
  4. Extractables & Leachables Assessment: We use state-of-the-art instrumentation to assess the presence of extractable and leachable substances from filters, cartridges and tubings ;  ensuring the absence of harmful compounds that could compromise the safety and quality of parenteral drugs.
  5. Bacterial Endotoxins: We verify the absence of any toxins that may have been generated by bacteria in the drug product prior the sterilization step.
  6. Particulate Matters and Non-Fiber Release determination: As per USP <788>, using either HIAC or Filtration techniques, we demonstrate the absence of particles in the drug product or that can be generated by the sterilization membrane itself.

Neopharm Answers to Common Questions About Filter Validation for Parenteral Drugs

Filter Validation for parenteral drugs refers to the process of evaluating and ensuring the effectiveness, integrity, and safety of filtration systems used in the manufacturing of sterile parenteral drug products. It involves various tests and assessments to validate the filters' ability to retain particles, microorganisms, and other contaminants, as well as to assess their compatibility with drug formulations.

Neopharm offers comprehensive Filter Validation services tailored specifically for parenteral drugs. Our services encompass filter integrity testing, compatibility studies, bacterial retention evaluation, bacterial endotoxins analysis, particulate matters verification, and assessment of extractables and leachables. These services provide a thorough evaluation of the filtration system's performance, compatibility with drug formulations, ability to retain bacteria, and absence of harmful substances that may migrate from the filter material.

Neopharm is committed to maintaining regulatory compliance in all aspects of our services. Our Filter Validation services adhere to industry regulations, guidelines, and standards, ensuring that your parenteral drug products meet the highest quality and safety requirements. Our team of experts is well-versed in the specific regulatory landscape, and we stay updated with the latest industry guidelines to provide you with compliant and reliable filter validation solutions.

At Neopharm, we understand that each client and filtration system is unique. We offer customized Filter Validation services tailored to your specific needs. Our experienced team considers your specific requirements, the characteristics of your parenteral drug products, and the regulatory environment to design a validation approach that best suits your filtration system. This customized approach ensures that our services are aligned with your objectives and deliver optimal results.

By choosing Neopharm, you benefit from our extensive experience in the pharmaceutical industry, our commitment to regulatory compliance, and our expertise in filter validation for parenteral drugs. We provide tailored solutions that address your specific needs, ensuring the highest standards of safety, quality, and efficacy for your products. Our accurate and reliable validation results, advanced techniques, and state-of-the-art equipment give you the confidence to make informed decisions about your filtration systems and meet the stringent requirements of the pharmaceutical industry.

Ensure the safety, quality, and regulatory compliance of your products through our expertise and commitment to excellence. Contact us now to discuss your specific requirements and benefit from our industry-leading filter validation solutions.

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