Pharmaceutical Guidelines

Blow Fill Seal (BFS) and Form Fill Seal (FFS) Technology in Sterile Manufacturing Know about sterile pharmaceutical production using Blow Fill Seal (BFS) and Form Fill Seal (FFS) technology. Both of these techniques are used to manufacture  sterile pharmaceutical products   as parenteral (LVP & SVP), infusions, ophthalmic and inhalation products. These are automated techniques to prepare sterile products. The basic concept of the  FFS   and BFS is to reduce the  contamination   by forming the container, filling and sealing in a closed sterile chamber of the machine. There is no personnel intervention to reduce the chances of the contamination during the manufacturing of sterile products. It gives more production at very low operational cost with the high assurance of  sterility . Blow fill seal technology is widely used and accepted by the various pharmaceutical regulatory authorities as US-FDA and MHRA. The system is being used for over 30 years a...

Aseptic Processing Area and Its Maintenance It is critical to maintain the aseptic manufacturing area because a lot of things may cause contamination in area including the personnel working in the area. A small contamination in area may cause contamination in whole batch. Good manufacturing practices   and regulations are critical areas for having good practices for the pharmaceutical industry. Much care should betaken especially when  manufacturing sterile drugs   and other biological products using aseptic processing. A critical area is where sterilized drugs,containers and closures may be exposed to the external conditions, therefore must be designed and manufactured to keep the product  sterility . Why is this so? Because an exposed product is vulnerable to  contamination . It may also not be sterilized in its immediate container. Therefore, the quality of an environment in which aseptic operations are being conducted, should be controlled and well maintain...

Aseptic Filling Process (Media Fill) Validation Protocol in Sterile Pharmaceuticals Validation of sterile manufacturing process by media fill validation test as per PICS guidelines for aseptic validation or aseptic process simulation. 1.0 OBJECTIVE 1.1 To define procedures for validating and maintaining the validation of all aseptic filling processes and qualification of the quality of the product by system/facility/equipment. 2.0 SCOPE 2.1 This procedure applies to all aseptically filled sterile products intended for human use. 3.0 RESPONSIBILITY 3.1 The Validation personnel coordinate the aseptic filling validation program and write the sterile media aseptic filling processes reports. 3.2 Manufacturing personnel the sterile media aseptic filling processes and performs the sterile media fills. 3.3 QA personnel perform the sampling and assist with the IPQA monitoring required for each sterile media fill. 3.4 QC personnel to perform the testing and assist with the monitoring required fo...

An Overview of ISO 14644 Clean Room Classification All classes of clean rooms, airborn particles and formula to calculate the number of sampling locations. The area having controlled airborne particle concentration is considered as the clean zone or clean room. These areas are constructed to minimize the introduction, generation, and retention of airborne particles in the area. The concentration of particles depends on their diameter; hence the bigger particles will be less in number than the smaller particles in any clean room environment. The airborne particles play a considerable role in aseptic processing because the viable particles i.e. bacteria, fungus etc. are associated with non-viable particles and may cause contamination in pharmaceutical sterile preparations. Classification of these areas are given in many guidelines but the base of all other guidelines is ISO i.e. ISO-14644-1 . A proper classification is given in ISO with the formula which gives the concentration of airbo...

Airlocks and Change Rooms in cGMP Facility Clean room area is the core area of pharmaceutical manufacturing that must be protracted from the contamination. Airlocks and change rooms help to protect the clean room area from contamination. A pharmaceutical GMP (Good Manufacturing Practices) facility has to be designed to minimize the risks involved in the pharmaceutical production those cannot be avoided through testing the final product. There is a protocol to follow the GMP system which ensures that the products are consistently produced and controlled according to quality standards. Cleanroom facilities are the space that is solely designed to perform such kind of clean processes inside the pharmaceutical facilities. Before entering the clean room, there are certain protocols and guidelines that personnel have to follow. Designing the airlock and change rooms with best safety measures helps the clean room to achieve maximum standards. An airlock is a room between the clean room and ...