Pharmaceutical Guidelines

Critical and Non-critical Areas in Pharmaceutical Manufacturing Sterile areas in pharmaceuticals where the sterile product is exposed to air are considered as critical area and other adjacent area are known as non-critical areas . Appropriate design, positioning and use of critical and non-critical areas in the pharmaceutical manufacturing process are among the key prerequisites for success in this industry. Critical areas include all areas in which any kind of sterile product (including both drugs and equipment) must be exposed to the sterile environment and where activities including sterilization, sterile filling and closing take place. Aseptic preparation and support rooms are also critical areas. All other areas in the manufacturing process are considered the non-critical areas. A well-designed flow of the work process which avoids critical and non-critical areas mixing must ensure avoiding contamination of any kind. Additionally, pharmaceutical industry laboratories require ext...

Criteria for Selection of Clean Room Garments in Pharmaceuticals Clean room must be protracted form all types of contamination. Clean room clothing is the main source of this contamination that can be eliminated by using of appropriate cloths. A clean room in the pharmaceutical industry is a specialized place that has very limited contaminants such as air particulates and chemicals so as to ensure the quality of the products produced is not only achieved but also maintained. In order to achieve such a sterile environment, the products, as well as clothing that enter the GMP clean room, should be of the highest quality to prevent bringing in any contaminants from other places.   Therefore, when selecting the cleanroom garments, the quality of the garment, as well as its cost, should be the key considerations. Employees also need a flexible garment that will not prevent them to work effectively in the cleanroom. The following factors need to be considered when choosing the right garm...

Controlled area in Sterile Pharmaceutical Manufacturing All pharmaceutical products are manufactured in controlled areas where the environmental conditions are controlled and product remain safe from temperature, humidity and contaminants during manufacturing. A controlled (classified) area is an enclosed environment or room with a flawless control over p articulate contamination . More specifically, the areas have a controlled contamination level, which is specified regarding the number of particles for every cubic meter, for a specified particle size. The restricted areas are constructed with impeccable humidity, temperature and pressure control to minimize the generation, introduction, and retention of particulate matter inside the  rooms. Used for sterile pharmaceutical manufacturing, the controlled areas ensure low levels of environmental pollutants, such as airborne microbes, dust, aerosol particles and chemical vapors. The classified rooms help the sterile pharmaceutical i...

  Clean Rooms and Controlled Areas (Sterile Area Classification) Learn the evaluation of Clean Rooms and Controlled Areas / sterile area clssification in sterile pharmaceuticals. MICROBIOLOGICAL EVALUATION OF CLEAN ROOMS AND OTHER CONTROLLED ENVIRONMENTS The purpose of this informational chapter is to review the various issues that relate to aseptic processing of bulk drug substances, dosage forms, and in certain cases, medical devices; and to the establishment, maintenance, and control of the microbiological quality of controlled environments. This chapter includes discussions on (1) the classification of a clean room based on particulate count limits; (2) microbiological evaluation programs for controlled environments; (3) training of personnel; (4) critical factors in design and implementation of a microbiological evaluation program; (5) development of a sampling plan; (6) establishment of microbiological Alert and Action levels; (7) methodologies and instrumentation used for ...