Product specific approach Vs overkill approach
Palash Chandra Das
SME In - Sterility Assurance | Aseptic practices | Airflow Visualisation |Failure investigation | FMEA | Q&V | Audit & Compliance | Technical consultation
Superheated water sterilizers are commonly used in healthcare settings, pharmaceutical manufacturing, and laboratories where steam sterilization may not be suitable due to the sensitivity of certain materials or the presence of heat-sensitive components. They offer an alternative method for achieving high-level disinfection and sterilization while minimizing the risk of damage to delicate instruments or equipment.
Please note that the specific limits, values, and acceptance criteria may vary depending on the sterilization method, industry, and regulatory requirements. It's essential to consult the relevant regulatory authorities (such as FDA in the US or EMA in Europe) and industry standards when establishing sterilization processes and conducting validation studies.
AGM at J.B.Pharmaceuticals
9 个月Overkill should be preferred wherever the product allows . It will certainly reduce the risk to patients due to not only mutation but also bacterial species identified during the course of mfg. and support data of media fill are performed. Also the validation of equipment and sterilization process are done with at most care.
Senior Manager Global Quality | GXP Quality Auditor | Supplier Quality
9 个月Thanks Palash Chandra Das amazing article