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Pharmaceutical Water Testing

Pharmaceutical Water Testing

Water plays a major role in the manufacturing, processing and formulation of pharmaceutical products, active pharmaceutical ingredients (APIs) and intermediates, compendial articles and analytical reagents. It is used in a variety of ways, including as a raw material, ingredient and solvent in such processes. As such, water must meet appropriate specifications for intended uses to ensure protection and production quality control. Pharmaceutical manufacturers are responsible for ensuring that water used in production processes meet regulatory and pharmacopeial specifications.

USP water testing and purified water standards are required for evaluating water quality and suitability for pharmaceutical manufacturing applications. It is critical that pharmaceutical manufacturers choose the appropriate water type and testing methods for intended product applications. Choosing an inappropriate water type could result in inflated production cost or losses due to remediation-related production delays. Moreover, water systems should be regularly sterilized, assessed and validated to prevent downstream contamination.

For best results, qualified analytical experts, like those at CPT Labs, should be called upon to assess both water and water system quality.

Our Capabilities

CPT has state-of-the-art analytical, microbiological, clinical, photobiology, and in-vitro toxicology testing laboratories, all of which are at your disposal in the determining of product safety, efficacy and efficiency.

Using our specialized departments and well-respected lab facility, we test a wide range of products at CPT. Our in-house experts offer guidance to determine the efficacy of your products while ensuring compliance and accommodating your budgetary concerns.

To provide thorough pharmaceutical water testing in preparation for product testing, CPT follows USP standards for testing water and water system quality. USP water testing approaches and standards provide the starting point for evaluating water quality and suitability for pharmaceutical manufacturing applications.

Our Departments

Based on the individual needs of our clients, we offer a wide range of support across various departments. Since initial product testing can be fairly complex in terms of a high-quality, safe and trusted product, our clients typically explore the benefits of numerous departments and areas of expertise, including:

  • Clinical — Efficacy trials can be performed for safety, consumer in-use, and to support claims such as ‘dermatologist-tested’ and ‘ophthalmologist-tested.’
  • In-Vitro Toxicology — Our In-Vitro Toxicology department assists clients when they are looking to perform non-animal (animal-free) toxicology testing.
  • Microbiology — Microbial contamination and preservative efficacy testing are key to cosmetic and OTC drug products.
  • Photobiology — From SPF and Water-Resistant claims to Photoallergy and Phototoxicity studies, CPT℠ is the world leader in sunscreen testing.
  • Analytical — From raw materials, product batch release, and stability shelf-life testing to “free-of” and low-level detection claims, our analytical department ensures that all requirements are met based on industry standards.
  • Consulting – Our consulting staff can perform GMP and GLP audits of your facilities or vendors, help create SOPs, develop testing programs, etc.

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