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 ...

A Different Approach to Validation and Re-validation of Washing Machine and a Depyrogenation Tunnel Learn a different approach to validate the washing machine and depyrogenation tunnel. Introduction The current economic situation has determined in the pharmaceutical field an increase of cost control necessity. This situation, joined with the difficulty of developing new molecules with both traditional streets with the latest generation (R&D outsourcing, biotechnologies) is putting under pressure all those activities that apparently does not lead to a gain, but rather, but are the cost for the company, like equipment validation and/or revalidation. This pressure, if not properly channeled, can lead to the belief that these activities are ends in themselves and generate only paper without any real benefit to the company in terms of knowledge of the process (knowledge in its broadest sense and not just in the act of production but also, of all that is ancillary to it and placing on ...

  Ultra Violet Light Disinfection in Pharmaceuticals Ultra Violet light is used for disinfection of purified water, treated effluent and pass boxes. Ultra violet light disinfection is also used in LAF unit. Ultraviolet light is used as a disinfection agent in pharmaceuticals. Short wavelengths of ultraviolet light create a harmful effect on microorganisms by  destroying their nucleic acids and prevent the growth of the microbial cells. First of all ultraviolet light is used for water disinfection is the United States in 1916. Now a day it is widely used to disinfect the drinking water and  wastewater. This is a low cost and very effective disinfection process. Ultraviolet light is short wavelength light than visible light having electromagnetic radiations. At a specific wavelength of 2537⁰A or 256 nm is harmful  to microorganisms and destroys the DNA of microbial cells. Thymine base of DNA and RNA is reactive with the ultraviolet radiations and forms  dimers (T=...