Pharma water chapter joe manfredi gmp systems, inc. Ispe international society for pharmaceutical engineering. Compressed air is considered a crucial service in pharmaceutical use, as most of its applications involve direct contact with the product. Last week, the international society for pharmaceutical engineering ispe published a guidance document titled ispe good practice guide. Ispe releases good practice guide on process gases flow. Trace analytics, llc is an a2la accredited laboratory specializing in compressed gas analysis for the breathing air, manufacturing, and medical gas industries worldwide. Loose debris or water soluble substances detergents, etc. Analyzing your products relationship with compressed air will allow your facility to determine appropriate purity class levels. Process gases has been sponsored by engineering executives from owner organizations, consulting firms, and ispe senior management.
According to ispe good practice guide 2016, compressed air can be used to dry a product, spray paint a product, move a product, or could even be included as a component or ingredient. Compressed air the overlooked element of cleanroom. Compressed air removal of large debris check for blockage rinsing rinsing is used to remove. Pdf qualification compressed air system pharmaceutical. According to ispe, the new guide aims to define current best practices within pharmaceutical manufacturing applications, specifically regarding gases that come into direct contact with the biopharmaceutical and pharmaceutical process steams, such. Ispe publishes guide for process gases biopharm international. Desiccant dryers using activated alumina will adsorb water vapor from the air most effectively, delivering iso 8573. Annex 5 supplementary guidelines on good manufacturing. If the specification you need is not shown, please contact us.
Based on useful work delivered, a 1hp compressed air motor consumes seven times as much energy as a comparable 1hp electric motor. A sourcebook for industryis a cooperative effort of the u. Compressed air is frequently used to blow water or dirt off of manufactured parts, similar to the way a leaf blower is used to clean a driveway. Process gases is to document accepted good processes and procedures within pharmaceutical manufacturing. The standard consists of nine separate parts, with part 1 specifying the quality requirements of the compressed air and parts 2 9 specifying the methods of testing for a range of contaminants. This good practice guide applies to manufacturers of pharmaceuticals, medical devices, biologics. Ispe publishes guide for process gases pharmaceutical. Compressed air for pharma plant good manufacturing. Compressed air is an important medium for transfer of energy in industrial processes, and is used for power tools such as air hammers, drills, wrenches and others, as well as to atomize paint, to operate air cylinders for automation, and can also be used to propel vehicles. Hi, we have qualified compressed air system as per iso 85731. Compressed gases for environmental monitoring european. Thus, the electrical costs of using compressed air can be significantly more than those. Secondarily, the exhaust for these types of equipment should be evaluated, based on the room criteria. Ispe good practice guide compressed air specifications.
Ispe urs for pharma equipment free download pdf ebook. It covers common compressed air design and operating. Compressed air piping recommendations for compressor. An official publication, containing a list of medicinal drugs with their effects and directions for their use called a pharmacopoeia have relatively inaccurate qualities compared to the standards required for pharmaceutical water requirements for compressed air. The quality of air supplied from a compressed air system will vary with application. Compressed air system comprises of air compressor chicago pneumatic india ltd. Compressed air is used in most manufacturing and some service industries, often where it is impractical or hazardous to use electrical energy directly to supply power to tools and equipment. Sampling for pharmaceutical water, pharmaceutical steam, and process gases water sampling chapter two primary groups to monitor and control chemical contaminants biological contaminants. Compressed air autoclaves, refrigerators, stability chambers, glassware washers approximately 20 different systems phase 1 project duration approximately 1 year 2005. The ispe good practice guide on sampling for pharmaceutical water, steam, and process gases was created for users of water, steam, compressed air or process gases and impacts facilities, production, and quality control personnel within a facility. Dec 03, 2018 the air quality is the measure of these contaminants in the compressed air.
Accreditation certificate compressed air testing trace. There will be several food trucks onsite for our event. Ukur dengan gc ispe indonesia affiliate seminar 8 december 2010 example testing instrument. According to ispe, the new guide aims to define current best practices within pharmaceutical manufacturing applications, specifically regarding gases that come into direct contact with the biopharmaceutical and pharmaceutical process steams, such as nitrogen, oxygen, argon, and compressed air. As shown in table 2, the testing and monitoring of compressed air and other process gases, such as gaseous and liquid nitrogen, oxygen, argon, and carbon dioxide, that come into direct contact with pharmaceutical drugs during the manufacturing process is vital to assuring the quality and safety of these products. Some air compressor vendors often improperly use acfm.
Pdf microbiological assessment of compressed gases in. If you are only powering valves and pumps, then the specs for this should apply. This guidebook addresses the typical compressed air systems common to most small and medium manufacturing facilities. Compressed air, nitrogen burning gas process gas co 2, o 2. Ispe good practice guide and compressed air compressed. Pharmaceutical compressed air quality gmp standards and. The purpose of this course is to present fundamentals and general information on compressed air systems. The guide defines current best practices in pharmaceutical manufacturing applications for handling gases that come into direct contact with the biopharmaceutical and pharmaceutical process steams e. Energy efficiency best practices and tips are suggested and emphasized. Compressed air is air kept under a pressure that is greater than atmospheric pressure. As such, it is important that the compressed air system used is designed, constructed and monitored well. The standard is made up of nine separate parts, part 1 specifying the quality requirements of the compressed air and parts 2 9 specifying the methods of testing for a range of contaminants. What are the compressed air standards in the pharmaceutical. The compressed air system operates well and is providing the level of purification required.
Good practice guides ispe international society for. Pharmaceutical utilities, current regulation, qualification and validation. Basic requirements for aseptic manufacturing of sterile. The air quality is the measure of these contaminants in the compressed air. Compressed air for pharma plant good manufacturing practice. Keep the small, portable kit, and return the lightweight sample via the shipping method of your choice. Taking this phrase literally, the natural assumption is that 1,000 actual cubic feet per minute of compressed air is leaving the discharge of the compressor at 100 psig. Compressed air and electrical supply are connected in accordance with the specifications and that all physical installation requirements have been met.
Connecting pharmaceutical knowledge ispe good practice guide. Sterile product manufacturing facilities third edition covers engineering aspects of designing new sterile products manufacturing facilities and modifications of existing facilities. Eere originally undertook this project as part of a series of sourcebook publications on industrial systems. For over 29 years, weve upheld the highest quality standards in the industry, delivering uncompromising quality in accordance with iso 8573, nfpa 1989, osha learn more. Our scientifically designed compressed air testing kits make collection a simple task. Process gases aims to define current good practices within pharmaceutical manufacturing applications, providing information to allow organizations to benchmark their practices, and improve upon them. This guide considers gases that come into direct contact with the biopharmaceutical. I think there is a usp monograph on compressed air. Jun 15, 2015 in the pharmaceutical industry, compressed air is used for a number of production and packaging applications, including blowing off and drying bottles prior to filling, conveying pills, providing air for pneumatically controlled valves and cylinders, as well as breathing air systems. Page 5 process gases table of contents 1 introduction 7. These compressed air cleanups, called blowoffs, typically include a pipe or a hose supplied with compressed air that feeds to one or more outlets or nozzles. Compressed gas can be supplied at source either sterile or nonsterile. Sampling for pharmaceutical water, steam, and process gases was created for users of water, steam, compressed air, or process gases and impacts facilities, production, and quality control personnel within a facility. For over 29 years, weve upheld the highest quality standards in the industry, delivering uncompromising quality in accordance with iso 8573, nfpa 1989, osh.
International society for pharmaceutical engineering ispe ihs markit is your source for ispe standards and publications. For example, an air compressor vendor may state that a 200 hp air compressor is rated for 1,000 acfm at 100 psig. If you are using compressed air in a sterile or clean environment, typically point of use filters are employed. Dew point, specified as temperature, is the point at which the water vapor held in the compressed air is equal to the compressed airs capacity to hold water vapor. The ispe good practice guide for process gases is shown below. Process gases and compressed air are used in a variety of ways depending on the product manufactured. These process streams include bodily contact surfaces of invasive medical devices and fluid paths of medical devices that are used for intravenous solution, blood, or other critical applications to administer life saving or sustaining fluids. Sterile product manufacturing facilities third edition.
This ensures a strong quality system that keeps contamination at bay. Ispeinternational society for pharmaceutical engineering. Compressed air is a form of stored energy that is used to operate machinery, equipment, or processes. Department of energys office of energy efficiency and renewable energy eere bestpractices and the compressed air challenge. In the pharmaceutical industry, compressed air is used for a number of production and packaging applications, including blowing off and drying bottles prior to filling, conveying pills, providing air for pneumatically controlled valves and cylinders, as well as breathing air systems. The water quality for each rinse step should be defined individually.