Tag: sterile

EU Annex 1 Audit Checklist for Contamination Control and Aseptic Processing

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| Audit, Sterility Assurance

  EU Annex 1 Audit Checklist is a practical resource designed to help pharmaceutical and sterile manufacturing professionals assess compliance with current EU Annex 1 requirements. The checklist covers contamination control strategy (CCS), clean room operations, aseptic processing, sterilization, environmental monitoring, validation, and quality systems, enabling teams to identify gaps, strengthen sterility assurance, and improve […]

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CAPA Assessment Report – High-Level Review of FDA 483 Observations

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| Audit, Drug regulatory and guidelines, News Updates

Introduction This report presents a high-level assessment of the Form FDA 483 issued to Sun Pharmaceutical Industries Ltd., Halol, dated June 13, 2025, following a comprehensive inspection by the United States Food and Drug Administration (USFDA). The inspection revealed eight major observations related to deficiencies in aseptic practices, process validation, equipment maintenance, data integrity, and […]

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EU Annex 1 compliance for superheated water steriliser – Part 1

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| Steam Sterilizer, Validation

“There should be routine checks on the equipment to ensure that nozzles (where the water is introduced) are not blocked and drains remain free from debris“. This technical assessment addresses the critical requirements for superheated water spray sterilization systems as specified in EU Annex 1, section 8.64. The document presents advanced engineering concepts and control […]

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Cycles for steam sterilisation and post-aseptic processing terminal heat treatment

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| Steam Sterilizer, Sterility Assurance, Validation

Sterilization Process Advisor – Tool Overview and Instructions The Sterilization Process Advisor is a simple and interactive tool designed to help users evaluate sterilization cycles, process hold temperatures, and understand the required information for quality dossier submissions. The tool provides tailored recommendations based on selected sterilization cycles and entered temperature values. <<<<Link for using the […]

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Q&A On Sterility Assurance

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| Sterility Assurance

#1. Why sterility assurance need to be ensure for sterile pharmaceutical preparations ? Sterility assurance is a crucial aspect in the production of sterile pharmaceutical products. It is the assurance that the final product is free of any viable microorganisms, which can cause harm to the patients. Ensuring the sterility of pharmaceutical products is important […]

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Mystery of Bio-burden over moist heat terminal sterilization process journey

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| Steam Sterilizer, Sterility Assurance

Monitoring of bioburden is one of the most important aspect of terminal sterilization. Before sterilization all samples to be collected based on the predetermined interval to cover the complete process/manufacturing time. Sample to be collected in the final container to represent to bioburden in the unsterile product bioburden at beginning, middle and end of the […]

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Growth in BI at Moist Heat Terminal Sterilization

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| Drug regulatory and guidelines, Steam Sterilizer, Technology

Terminal sterilization is the reliable process to assure the sterility of the product. Regulators more relay on the Moist heat terminal sterilization process than aseptic processing. In terminal sterilization product sterilized in the final container. Terminal sterilization should be utilized when the product and container/closure system are able to withstand the terminal sterilization process. Note: Kindly […]

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A Tale of Infection

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| Industrial Microbiology, Sterility Assurance

What is infection? The invasion and multiplication of microorganisms such as bacteria, viruses, and parasites that are not normally present within the body. An infection may cause no symptoms and be subclinical, or it may cause symptoms and be clinically apparent. An infection may remain localized, or it may spread through the blood or lymphatic […]

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