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Cleaning validation is an important element to cGMP manufacturing to ensure purity, quality, and potency of drug product.
All drug products have to undergo sterility testing to comply with Good Manufacturing Practices (GMP). Rapid sterility testing, which offers an incubation period of five days or less, provides a solution.
The manufacturing process does not always allow for immediate transfer of samples to the incubator space and may be pre-stored.
This paper provides scientific guidance as well as a case study on the effect of solvent polarity (ethanol/water proportion) on the levels of extractables.
This whitepaper considers the chemical properties of commonly encountered acidic and basic extractables and uses these properties to address questions about establishing the proper pH (or proper pH range).
The Capsugel® R&D portfolio features capsule and related service solutions for faster research and development during pre-clinical and clinical stages.
Biologics continue to be a major modality in the pharmaceutical pipeline. New and unique LC-MS tools will become available for use from discovery through QC.
Airflow reduction and energy savings achieved in HVAC compared to conventional systems. The challenge of reducing HVAC energy consumption and operation costs without negatively affecting the quality of the finished products, ensuring cleanrooms always conform to required specifications
With the growing trend of injection device use at home, the device optimisation is essential to increase patient safety during self-administration.
Extensive portfolio of quality control solutions. Full regulatory compliance (USP, EP, JP Pharmacopoeias) of your sterility testing workflow.
A typical cleaning validation (CV) programme consists of three phases: Design, Validation and Continued Verification.
Syringe membrane filter selection/validation methods to assess analyte loss due to membrane filter adsorption in pharmaceutical quality control tests.
Why do E&L testing? Extractables & leachables studies enable drug sponsors to quantify and identify the risks of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment or packaging.
This whitepaper from NSF looks at the key causes of drug shortages and what we can do to stop them.
New trends in automation and process control for sterilisation systems by integrating robotised loading and unloading technology.
