Tag: SOP for autoclave sterilization

Sterile Injectable Manufacturing: SOP for Sanitization of Portable Water Systems – V 2.0

Sterile Injectable Manufacturing: SOP for Sanitization of Portable Water Systems – V 2.0 Standard Operating Procedure for Sanitization of Portable Water Systems Department Sterile Injectable Manufacturing SOP No. SOP/SIM/160/2025 Supersedes SOP/SIM/160/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose This SOP describes the method for routine…

Injectables V 2.0

Sterile Injectable Manufacturing: SOP for Routine Maintenance and Cleaning of Packing Machines – V 2.0

Sterile Injectable Manufacturing: SOP for Routine Maintenance and Cleaning of Packing Machines – V 2.0 Standard Operating Procedure for Routine Maintenance and Cleaning of Packing Machines Department Sterile Injectable Manufacturing SOP No. SOP/SIM/159/2025 Supersedes SOP/SIM/159/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose This SOP provides…

Injectables V 2.0

Sterile Injectable Manufacturing: SOP for Ensuring No Residue Post-Cleaning of Machines – V 2.0

Sterile Injectable Manufacturing: SOP for Ensuring No Residue Post-Cleaning of Machines – V 2.0 Standard Operating Procedure for Ensuring No Residue Post-Cleaning of Machines Department Sterile Injectable Manufacturing SOP No. SOP/SIM/158/2025 Supersedes SOP/SIM/158/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose This SOP describes the process…

Injectables V 2.0

Sterile Injectable Manufacturing: SOP for Use of CIP Systems in Cleaning Lyophilizers – V 2.0

Sterile Injectable Manufacturing: SOP for Use of CIP Systems in Cleaning Lyophilizers – V 2.0 Standard Operating Procedure for Use of CIP Systems in Cleaning Lyophilizers Department Sterile Injectable Manufacturing SOP No. SOP/SIM/157/2025 Supersedes SOP/SIM/157/2022 Page No. Page 1 of 15 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose This Standard Operating…

Injectables V 2.0

Sterile Injectable Manufacturing: SOP for Cleaning and Disinfecting Cleanroom Pass-Through Chambers – V 2.0

Sterile Injectable Manufacturing: SOP for Cleaning and Disinfecting Cleanroom Pass-Through Chambers – V 2.0 Standard Operating Procedure for Cleaning and Disinfecting Cleanroom Pass-Through Chambers Department Sterile Injectable Manufacturing SOP No. SOP/SIM/156/2025 Supersedes SOP/SIM/156/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To define the standardized method…

Injectables V 2.0

Sterile Injectable Manufacturing: SOP for Sanitization of Isolators in Sterile Manufacturing – V 2.0

Sterile Injectable Manufacturing: SOP for Sanitization of Isolators in Sterile Manufacturing – V 2.0 Standard Operating Procedure for Sanitization of Isolators in Sterile Manufacturing Department Sterile Injectable Manufacturing SOP No. SOP/SIM/155/2025 Supersedes SOP/SIM/155/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To define the procedure for…

Injectables V 2.0

Sterile Injectable Manufacturing: SOP for Documenting Cleaning Validation Reports – V 2.0

Sterile Injectable Manufacturing: SOP for Documenting Cleaning Validation Reports – V 2.0 Standard Operating Procedure for Documenting Cleaning Validation Reports Department Sterile Injectable Manufacturing SOP No. SOP/SIM/154/2025 Supersedes SOP/SIM/154/2022 Page No. Page 1 of 15 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose This SOP defines the procedure for proper documentation of…

Injectables V 2.0

Sterile Injectable Manufacturing: SOP for Post-Cleaning Inspection of Filling Lines – V 2.0

Sterile Injectable Manufacturing: SOP for Post-Cleaning Inspection of Filling Lines – V 2.0 Standard Operating Procedure for Post-Cleaning Inspection of Filling Lines Department Sterile Injectable Manufacturing SOP No. SOP/SIM/153/2025 Supersedes SOP/SIM/153/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose This SOP defines the systematic procedure for…

Injectables V 2.0

Sterile Injectable Manufacturing: SOP for Use of Cleaning Agents in Sterile Equipment Cleaning – V 2.0

Sterile Injectable Manufacturing: SOP for Use of Cleaning Agents in Sterile Equipment Cleaning – V 2.0 Standard Operating Procedure for Use of Cleaning Agents in Sterile Equipment Cleaning Department Sterile Injectable Manufacturing SOP No. SOP/SIM/152/2025 Supersedes SOP/SIM/152/2022 Page No. Page 1 of 13 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To…

Injectables V 2.0

Sterile Injectable Manufacturing: SOP for Cleaning Validation of High-Pressure Pumps – V 2.0

Sterile Injectable Manufacturing: SOP for Cleaning Validation of High-Pressure Pumps – V 2.0 Standard Operating Procedure for Cleaning Validation of High-Pressure Pumps Department Sterile Injectable Manufacturing SOP No. SOP/SIM/151/2025 Supersedes SOP/SIM/151/2022 Page No. Page 1 of 14 Issue Date 24/06/2025 Effective Date 26/06/2025 Review Date 24/06/2026 1. Purpose To define a standard procedure for the…

Injectables V 2.0