Medicines and other healthcare products rely for their value, integrity and commercial longevity on a delicate balance between quality, safety and efficacy.
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Lyophilized drug product containers and administration devices consist of the primary packaging, the reconstitution solution container, and the drug administration set.
Nelson Laboratories, with their unique database of over 6,000 compounds for detection, discuss the testing requirements for extractables and leachables and why identification and quantification in extraction studies will become increasingly crucial for pharmaceutical and medical device product safety and integrity.
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.
This webinar will address the evaluation of microbiological, environmental monitoring data as well as what would be considered significant differences in data.
Whitepaper: Establishing the proper alcohol/water proportion for simulating solvents used in controlled extraction studies
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.
Stability testing is a vital part of product development and is conducted throughout a product’s life cycle.
Whitepaper: Establishing the proper PH range for aqueous simulating solvents used in extractables profiling
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).
Sterility assurance for a pharmaceutical product is critical, and includes many aspects outside of the actual sterilization cycle or aseptic process.
The purpose of this Position Paper is to consider the scientific basis for accelerating extractables and/or leachables studies via the proper combination of contact temperature and duration (time). Considering this scientific basis, recommendations concerning proper acceleration strategies are provided.
The purpose of this Technical Communication is to establish how General Chemistry Data obtained in controlled extraction studies, such as pH, UV absorbance and total organic carbon (TOC), is reported, used and discussed as part of a rigorous extractables assessment.