Extractables and Leachables Testing Services - Vimta Labs Ltd
Packaging materials & manufacturing components coming in contact with drug products, active ingredients or medical devices are a potential source for chemical contamination, posing a risk to product safety and quality. A detailed study of container closure system, manufacturing components and drug product is becoming increasingly necessary to evaluate the impact of such interactions. Extractable and Leachable study is a critical regulatory requirement which requires thorough understanding of the subject, extensive experience, high end instrumentation and qualified resource. VIMTA provides customized protocol driven extractables and leachables testing services to help ensure that your product is safe for the patient. Our scientific team is well versed with applicable regulatory requirements, standards and guidelines such as PQRI, FDA, ISO, EMEA, ICH, EP and USP, in addition to its decades of experience in analytical and physical chemistry. Our cGMP facilities offer a proven track record in carrying out studies of extractables and leachables to detect ultra-trace levels of contaminants from materials in contact with drug products or medical devices. VIMTA has successfully faced over 70 regulatory audits including 16 US FDA inspections and has an excellent track record of delivering high quality services to its global customers. Visit our website https://www.vimta.com for more details
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