Tag: Aseptic technique in sterile manufacturing

Sterile Injectable Manufacturing: SOP for Cleaning of Laminar Flow Cabinets in Cleanrooms – V 2.0 Standard Operating Procedure for Cleaning of Laminar Flow Cabinets in Cleanrooms Department Sterile Injectable Manufacturing SOP No. SOP/SIM/054/2025 Supersedes SOP/SIM/054/2022 Page No. Page 1 of 14 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To establish a…

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Sterile Injectable Manufacturing: SOP for Cleaning of Autoclaves Used in Sterile Manufacturing – V 2.0 Standard Operating Procedure for Cleaning of Autoclaves Used in Sterile Manufacturing Department Sterile Injectable Manufacturing SOP No. SOP/SIM/053/2025 Supersedes SOP/SIM/053/2022 Page No. Page 1 of 14 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To define a…

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Sterile Injectable Manufacturing: SOP for Cleaning of Lyophilizers Post-Batch Processing – V 2.0 Standard Operating Procedure for Cleaning of Lyophilizers Post-Batch Processing Department Sterile Injectable Manufacturing SOP No. SOP/SIM/052/2025 Supersedes SOP/SIM/052/2022 Page No. Page 1 of 13 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To establish a detailed and validated procedure…

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Sterile Injectable Manufacturing: SOP for Cleaning of Injectable Filling Machines – V 2.0 Standard Operating Procedure for Cleaning of Injectable Filling Machines Department Sterile Injectable Manufacturing SOP No. SOP/SIM/051/2025 Supersedes SOP/SIM/051/2022 Page No. Page 1 of 14 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To define the procedure for effective and…

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Sterile Injectable Manufacturing: SOP for Handling Power Failures during Machine Operations – V 2.0 Standard Operating Procedure for Handling Power Failures during Machine Operations Department Sterile Injectable Manufacturing SOP No. SOP/SIM/050/2025 Supersedes SOP/SIM/050/2022 Page No. Page 1 of 13 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To define the standard procedure…

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Sterile Injectable Manufacturing: SOP for Calibration of Temperature Control Systems in Filling Machines – V 2.0 Standard Operating Procedure for Calibration of Temperature Control Systems in Filling Machines Department Sterile Injectable Manufacturing SOP No. SOP/SIM/049/2025 Supersedes SOP/SIM/049/2022 Page No. Page 1 of 14 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To…

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Sterile Injectable Manufacturing: SOP for Troubleshooting Filling Machine Issues – V 2.0 Standard Operating Procedure for Troubleshooting Filling Machine Issues Department Sterile Injectable Manufacturing SOP No. SOP/SIM/048/2025 Supersedes SOP/SIM/048/2022 Page No. Page 1 of 13 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To outline the systematic procedure for troubleshooting technical and…

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Sterile Injectable Manufacturing: SOP for Cleanroom Pass-Through Equipment Operation – V 2.0 Standard Operating Procedure for Cleanroom Pass-Through Equipment Operation Department Sterile Injectable Manufacturing SOP No. SOP/SIM/047/2025 Supersedes SOP/SIM/047/2022 Page No. Page 1 of 12 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To establish a standard procedure for the correct and…

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Sterile Injectable Manufacturing: SOP for Prefilled Syringe Filling Machine Operation – V 2.0 Standard Operating Procedure for Prefilled Syringe Filling Machine Operation Department Sterile Injectable Manufacturing SOP No. SOP/SIM/046/2025 Supersedes SOP/SIM/046/2022 Page No. Page 1 of 13 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To define the procedure for the operation…

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Sterile Injectable Manufacturing: SOP for Setting Parameters for Vial Filling Machines – V 2.0 Standard Operating Procedure for Setting Parameters for Vial Filling Machines Department Sterile Injectable Manufacturing SOP No. SOP/SIM/045/2025 Supersedes SOP/SIM/045/2022 Page No. Page 1 of 14 Issue Date 18/06/2025 Effective Date 20/06/2025 Review Date 18/06/2026 1. Purpose To establish a standardized procedure…

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