SOP For Washing, Preparation, and Sterilization of Sterile Garments 1.0 Objective 1.1 To establish a procedure for the washing, preparation, sterilization, inspection, and handling of sterile garments to ensure their suitability for use in sterile areas. 2.0 Scope 2.1 This SOP is applicable to all sterile garments used in the Production Department, including their washing, … Read more
SOP For Operation and Cleaning of Laminar Air Flow (LAF) Workstation 1.0 Objective 1.1 To establish a procedure for the operation and cleaning of Laminar Air Flow (LAF) workstations to ensure a controlled, particle-free working environment. 2.0 Scope 2.1 This SOP is applicable to the operation and cleaning of Laminar Air Flow (LAF) workstations in … Read more
SOP For Cleaning of Prefilter of Laminar Air Flow (LAF) 1.0 Objective 1.1 To establish a procedure for the cleaning of prefilters of Laminar Air Flow … Read more
SOP For Fogging of Sterile Area 1.0 Objective 1.1 To establish a procedure for fogging of sterile areas to maintain microbiological control and ensure a contamination-free environment. 2.0 Scope 2.1 This SOP is applicable to the fogging of sterile areas in the Production Department, including associated rooms and airlocks. 3.0 Responsibility 3.1 Operator – Production … Read more
SOP for Ethylene Oxide (EO) Sterilization Validation 1. Purpose To describe the procedure for validation and routine monitoring of the Ethylene Oxide (EO) sterilization process using the overkill method (AAMI/ISO 11135 Method C) to ensure that the sterilization process consistently achieves the required Sterility Assurance Level (SAL) for medical devices. 2. Scope This SOP applies … Read more
Finishing of Sterile Products WHO GMP Questions 1. Containers should be closed by: A. Random methodsB. Appropriately validated methodsC. Visual inspection onlyD. Manual sealing without validationAnswer: B Questions 2. Containers closed by fusion, such as glass or plastic ampoules, should be: A. Tested in 10% of unitsB. Subject to 100% integrity testingC. Not tested if visually intactD. … Read more
Equipment WHO GMP Questions 1. A conveyor belt should not pass through a partition between a Grade A/B clean area and a lower-grade processing area unless: A. The belt is painted regularlyB. The belt is continuously sterilized (e.g., in a sterilizing tunnel)C. Personnel supervise it constantlyD. The belt is made of stainless steelAnswer: B Questions 2. Equipment … Read more
Premises WHO GMP Questions 1. Grade A and B areas should be designed so that operations can be: A. Conducted only by supervisorsB. Observed from outsideC. Hidden from viewD. Monitored by external cameras onlyAnswer: B Questions 2. All exposed surfaces in clean areas should be: A. Rough and porousB. Smooth, impervious, and unbrokenC. Painted with any coatingD. … Read more
Personnel in clean areas WHO GMP Questions 1. In clean areas, the number of personnel present should be: A. As many as possibleB. Only the minimum requiredC. Determined by convenienceD. Twice the normal staffAnswer: B Questions 2. During aseptic processes, inspections and controls should be conducted: A. Only from inside the clean areaB. As far as possible from … Read more
Blow/fill/seal technology WHO GMP Questions 1. Blow/fill/seal (BFS) units are designed to: A. Only fill pre-formed containersB. Form containers, fill, and seal them in one continuous operationC. Sterilize containers separatelyD. Only seal containers after manual fillingAnswer: B Questions 2. BFS equipment forms containers from: A. Glass sheetsB. Thermoplastic granulateC. Metal alloysD. Pre-sterilized plasticsAnswer: B Questions 3. For aseptic … Read more
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