Efficacy or adequacy of a depyrogenation process can be assessed by spiking containers and closures with known quantities of endotoxin, followed by measuring endotoxin content after depyrogenation. The challenge studies can generally be performed by directly applying a reconstituted endotoxin solution onto the surfaces being tested. The endotoxin solution should then be allowed to air…
What are bacterial toxins , endotoxin , exotoxins :In simple words bacterial toxins are classified in to two categories.1.Exotoxins. 2.Endotoxins. 1.Exotoxins:- Exotoxins is a proteinaceous substance secreted by any bacterial cell and secreted out of cell , this toxins may harm any other living cell which come in contact with it , it may cause cell wall rupture…
Aspects of aseptic process isolator in sterile dosage form manufacturing. Aseptic processing with use of isolation systems separates the external cleanroom environment from the aseptic processing line and minimizes its personnel exposure. A properly designed positive pressure isolator,along with adequate procedures for its maintenance, monitoring, and control, provides great advantages over traditional aseptic processing of…
Media Fill Run to ensure the sterility Sterile dosage form evaluation of manufacturing process by Process Simulations /media fill run Validation of sterile dosage form manufacturing is devided in to three parts A. Process Simulations : B. Filtration Efficacy.C. Sterilization of Equipment, Containers, and Closures : Filtration Efficacy and Sterilization of Equipment, Containers, and Closures…
Important Aseptic techniques ,in aseptic manupulations , Aseptic Process Sterile drug manufacturing Personnel training,qualification,monitoring, things to do and tings should not do , We are providing some of the Aseptic techniques aimed at maintaining sterility of sterile items and surfaces include: 1. Contact sterile materials only with sterile instruments Sterile instruments should always be used…
Aspects of Validation of Aseptic Process and Sterilisation , Sterilization of Equipment, Containers, and Closures We had divided topic “Aspects of Validation of Aseptic Process and Sterilisation” in to three parts . A. Process Simulations :This process simulation, also known as a media fill , We have a very good article over this blog about Media…
VALIDATION OF ASEPTIC PROCESSING AND STERILIZATION In this series of articles we are going to disscus aspects of Validation of Aseptic Process and Sterilisation routine qualifications and validation study recommendations . Change control procedures are an important part of the quality systems established by any firm. A change in facility, equipment, process, or test method…
21 CFR 211.111 states that “When appropriate, time limits for the completion of each phase of production shall be established to assure the quality of the drug product. Deviation from established time limits may be acceptable if such deviation does not compromise the quality of the drug product. Such deviation shall be justified and documented.”…
Aseptic processes are designed to minimize exposure of sterile articles to the potential contamination hazards of the manufacturing operation. Limiting the duration of exposure of sterile product elements, providing the highest possible environmental control, optimizing process flow, and designing equipment to prevent entrainment of lower quality air into the Class 100 (ISO 5) clean area…
Blow-fill-seal (BFS) technology is an automated process by which containers are formed, filled, and sealed in a continuous operation.A well-designed BFS system should also normally achieve Class 100 (ISO 5) airborne particle levels. Only personnel who have been qualified and appropriately gowned should enter the classified environment surrounding the BFS machinery. BLOW-FILL- SEAL TECHNOLOGY Blow-fill-seal…