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ACM Provides Cleanroom Training and Certification for CePAT in Ghana, Africa
Poor-quality medicines pose a serious threat to public health in Sub-Saharan Africa. USP–Ghana, home to the Center for Pharmaceutical Advancement and Training (CePAT), provides high-quality analytical and training services to help national regulatory authorities and local manufacturers detect falsified and substandard medicines, and to ensure sustainable, quality-assured medicines production. CePAT also screens pharmaceuticals for quality from across the sub-region.
ACM is very proud to lend support to CePAT on this effort and on DEC 12th – 14th conducted remote training sessions to the CePAT staff on cleanroom standards, aseptic gowning and cleanroom cleaning and will also continue to provide ISO cleanroom certification to their facilities on Africa’s west coast. By utilizing the latest technology in web training ACM can now better reach remote areas of Africa in order to deliver training assistance and support the WHO, USP and pharmaceutical partners in helping protect and save lives across the globe.
For more information on the U.S. Pharmacopeial Convention (USP) please visit their website at http://www.usp.org/about-usp.
To Learn more about ACM’s cleanroom facility services, please visit us at http://advancedcleanroom.com/
ACM Training Managers Demonstrate Cleaning procedure to the CePAT Team in Ghana, Africa remotely from ACM’s offices in PA.
Optimizing Facilities Management in the Pharma Industry A Q&A with UMS Advisory
Optimizing Facilities Management in the Pharma Industry
A Q&A with UMS Advisory
In the era of manufacturing capacity rationalizaton, tighter return on assets, and re-alignment of manufacturing assets to meet changing product demand, strategies for cost-effectively managing manufacturing and other facilities become ever-more crucial.
Feb 06, 2013
By Patricia Van Arnum
PTSM: Pharmaceutical Technology Sourcing and Management Effective management of manufacturing facilities is an important consideration for pharmaceutical/biopharmaceutical companies, particularly in an era of plant consolidation, restructuring, and a need to maintain of achieve higher returns on capital. Patricia Van Arnum, executive editor of Pharmaceutical Technology and editor of Sourcing and Management, recently spoke to Rakesh Kishan and Eric Grey, senior consultant, both at UMS Advisory to gain a perspective on best practices in facilities management.
PharmTech: The pharmaceutical industry as a whole has undergone and continues to undergo restructuring, including manufacturing plant rationalization. In managing an evolving manufacturing and supply network, what would you identify as the key requisites in facilities management to facilitate product transfer and potential ownership changes in a given facility. What are some of the main pitfalls arising in facilities management that may impede those changes in product transfer and ownership changes?
Kishan: A key priority for facilities management in today’s changing manufacturing supply network is to shift to variable cost and a flexible structure. Flexibility in the workforce and contracts are vital in a manufacturing environment characterized by product transfer and ownership changes. These changes can be impeded by a fixed cost structure that offers little variability. As plants rationalize or reposition their missions, facilities management should align facilities-management asset-management strategy in light of the manufacturing strategy. Today, it is still possible to find facilities-management asset-maintenance strategiesthat are designed around redundancy for assets whose criticality to production has been downgraded. As plant strategies change, facilities management needs to re-align its approach and the delivery model and risk-acceptance profile that needs to filter right through to facilities-management standards and procedures. A key area for facilities-management contribution to the business will be through strategic portfolio planning. As plant networks change, facilities management can offer strategic space and capacity-planning solutions through new “site of the future” concept models, different asset-ownership structures, and new, flexible delivery models based on analytic visibility into lifecycle costs. Although portfolio planning is important, facilities management also needs to address the important requirements of the site heads and other site stakeholders. This they can do by engaging stakeholders in site master planning to further hone and refine the site- level strategy for facilities-management operations. In sum, facilities management needs to align the portfolio strategy both financially and operationally with the business while keeping a clear site-level focus on asset strategy, workplace services, as well as site master planning.
PharmTech:The pharmaceutical industry is intensifying its product development in biologic-based drugs. Given the higher capital costs associated with biopharmaceutical manufacturing facilities, what would you identify as some best practices inoptimizing facilities management at a biopharmaceutical manufacturing facility? What are some of the unique considerations that need to be taken into account? Kishan: Facilities-management equipment and systems are more closely connected with product in biologic facilities. High-purity systems and their operations and maintenance are far more closely linked to production in a biologic facility. Consequently, biologic-based drug-manufacturing facilities-management organizations need to have very strong planning and scheduling processes that are tightly integrated into production planning and scheduling. The yield-driven biologics production environment can be by far very dynamic when compared with a fixed-schedule pharmaceutical manufacturing environment. Consequently, facilities-management can create value by ensuring effective interfaces with manufacturing and shifting their maintenance and engineering support based on real-time information. Facilities management’s ability to provide reliable utilities and operational solutions for advanced cleaning and maintenance technologies designed specifically for sterile and high-corrosion environments is a source of value in biologics sites. Facilities management’s should also become operationally more cross-functional and flexible to enable quicker equipment shifts across multiple product-recipe trains while maintaining production environment integrity. Optimizing Facilities Management in the Pharma Industry In the era of manufacturing capacity rationalizaton, tighter return on assets, and re-alignment of manufacturing assets to meet changing product demand,
strategies for cost-effectively managing manufacturing and other facilities become ever-more crucial.
PTSM: With the pharmaceutical industry facing increased cost pressures, what metrics do you think best evaluate plant performance and operation? Can you be specific in terms of either traditional or new metrics relating to return on capital and asset optimization?
Grey: Most companies use several measures to gauge plant performance and operations. Any time one thinks about measurement, one has to be mindful of three key facts: No single measure is perfect; not everything important can be measured (for example, shop floor leadership is a strong predictor of plant uptime); and hence, it’s a balance of measures that count the most. Too many measures typically suggest a lack of focus on what truly matters. The measures we typically see are:
• Cost/unit: A bottom-line efficiency metric, important particularly in light of competition from low-cost countries;
• Yield: A measure of production-material effectiveness and waste
• Inventory turns: Measures working-capital effectiveness
• Right-first-time: Measures transactional waste
• Overall equipment effectiveness (OEE): Measures equipment utilization, productivity, and effectiveness.
It is very important to recognize interdependencies across the measures. A single- minded focus on solving for a particular measure can end up creating problems in other parts of the operation. For example, a site that may focus on cost/unit may reduce the expertise required to solve problems both on the floor and in the offices, which in turn creates more material and transactional waste.Or a site may use inventory to buffer against operational issues at the expense of working capital rather than address root causes. Alternatively, a site may add labor to improve right-first-time but drive up the cost/unit, which may also be influenced by the regulatory environment at the site. But there are instances where a single overarching measure can drive improvements in another hierarchy of metrics. For example a site focused on improving OEE found it had to also get the right-first-time improved to prevent paperwork delaying production and also reduce its inventory (increasing inventory turns) in order to achieve sustained results. OEE drove maintenance and facilities groups to work more closely together in order to ensure the assets were available for production when needed.
PharmTech: Emerging markets are a growth area for the pharmaceutical industry, where pharmaceutical companies may partner with domestically domiciled companies or seek to build their own manufacturing base in a country. What are some of the buy/partner decision points that a company should take into consideration?
Kishan: Overseas manufacturing and laboratories are being positioned as the “lab of the future” or as the “manufacturing plant of the future,” as new sites are designed and configured in emerging markets. In these environments, facilities-management services and delivery models can be designed and configured to offer flexible, high-performing solutions without facing legacy constraints. Facilities management has the opportunity to pursue different “make or buy,” “partner/own” choices in their delivery models from the outset. For example, one pharmaceutical site elected to bring in an operating facilities-management supplier during the design phase to ensure that operability and maintenance perspectives were incorporated into the design phase of the facility. As the facility started to come on line, the site also then purchased a new service solution from the supplier to provide an integrated set of facilities-management services at the site, where the supplier could leverage their knowledge and input from the design, commissioning, and equipment warrantees into their maintenance and service delivery solution.
More on FM in Pharma >> http://www.pharmtech.com/strategies-outsourcing-facilities-management
Evolution of the Clean Room January 11, 2011 By John Buie
Although the principles of clean room design go back more than 150 years to the beginning of bacterial control in hospitals, the clean room itself is a relatively modern development. It was the need for a clean environment for industrial manufacturing during the 1950s that led to the modern clean room as we know it. A clean room is a rigorously controlled environment that has a low level of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapors. The air entering a clean room is filtered and then continuously circulated through high efficiency particulate air (HEPA) and/or ultra-low particulate air (ULPA) filters to remove internally generated contaminants. Staff wearing protective clothing must enter and exit through airlocks, while equipment and furniture inside the clean room is specially designed to produce minimal particles. While more than 30 different industry segments utilize clean rooms, 70 percent of U.S. clean room floor space is in the semiconductor and other electronic components, pharmaceutical, and biotechnology industries.
1939 – 1945
Development of the modern clean room began during the Second World War to improve the quality and reliability of instrumentation used in manufacturing guns, tanks and aircraft. During this time, HEPA filters were also developed to contain the dangerous radioactive, microbial or chemical contaminants that resulted from experiments into nuclear fission, as well as research into chemical and biological warfare.
While clean rooms for manufacturing and military purposes were being developed, the importance of ventilation for contamination control in hospitals was being realized. The use of ventilation in a medical setting gradually became standard practice during this time.
1950s – 1960s
The evolution of clean rooms gained momentum as a result of NASA’s space travel program in the 1950s and 1960s. It was during this time that the concept of ‘laminar flow’ was introduced, which marked a turning point in clean room technology. In the late 1950s, Sandia Corporation (which later became Sandia National Laboratories) began investigating the excessive contamination levels found in clean rooms. Researchers found that clean rooms were being operated at the upper practical limits of cleanliness levels and identified a need to develop alternative clean room designs. In 1960, Blowers and Crew in Middlesborough, UK was the first to improve contamination control by creating a unidirectional airflow from an air diffuser fitted over the entire ceiling in an operating room. In practice, the airflow was disturbed by air currents and the movement of people, but the idea of unidirectional flow was born. Also in 1960, McCrone Associates began developing advanced particle handling techniques using tungsten needles and collodion. These techniques, which later became industry standards, were incorporated into the McCrone Associates Class 100 clean room. In 1961, Professor Sir John Charnley and Hugh Howorth, working in a hospital in Manchester, UK, managed to significantly improve unidirectional airflow by creating a downward flow of air from a much smaller area of the ceiling, directly over the operating table.
Also in 1961, the first standard written for clean rooms, known as Technical Manual TO 00-25-203, was published by the United States Air Force. This standard considered clean room design and airborne particle standards, as well as procedures for entry, clothing and cleaning. In 1962, Sandia Corp. launched the Whitfield Ultra-clean room, which was publicized in Time Magazine, creating a great deal of interest. Instead of simply using filters to clean incoming air, Whitfield used filtered air to keep the room clean by introducing a change of ultra-clean air every six seconds. In 1962, Patent No. 3158457 for the laminar flow room was issued. It was known as an “ultra clean room.” By 1965, several vertical down flow rooms were in operation in which the air flow ranged between 15 m (50 ft)/min and 30 m (100 ft)/min. It was during this time that the specification of 0.46 m/s air velocity and the requirement for 20 air changes an hour became the accepted standard. In 1966, Patent No. 3273323 was submitted and issued for the “laminar flow airhood apparatus.” 1970sBy the early 1970s the principle of “laminar flow” had been translated from the laboratory to wide application in production and manufacturing processes.
1980s – 1990s
The 1980s saw continued interest in the development of the clean room. By this stage, clean room technology had also become of particular interest to food manufacturers.
During the late 1980s, STERIS (formerly known as Amsco) developed the use of hydrogen peroxide gas for the decontamination of clean rooms, and marketed the idea under the trademark VHP (vaporized hydrogen peroxide). Hydrogen peroxide gas rapidly became the most widely used method of sterilization, due to its unique combination of rapid antimicrobial efficacy, material compatibility and safety. In 1980, Daldrop + Dr.Ing.Huber developed an innovative clean room ceiling, known as ‘Euro Clean’, to meet the rising challenges from industry at the beginning of the 80s. In 1987, a patent was filed for a system of partitioning the clean room to allow zones of particularly high-level cleanliness. This improved the efficiency of individual clean rooms by allowing areas to adopt different degrees of cleanliness according to the location and need. In 1991, a patent was filed for a helmet system that can be used in a medical clean room in which the user is protected from contaminated air in the environment, while the patient is protected from contaminated air being exhausted from the user’s helmet. Such a device decreases the possibility of operating room personnel being contaminated with viruses carried by the patients being operated upon. In 1998/1999, CRC Clean Room Consulting GmbH introduced the clean room filter fan. This involved the integration of a filter fan unit, with filter, ventilator, and motor directly into the clean room ceiling.
The pace of clean room technology transformation has accelerated over recent years. Since the year 2000, there have been significant advances in new clean room technology, which have helped to streamline manufacturing and research processes, while also reducing the risk of contamination. Most of the
technological developments of the past decade have been directed towards the manufacture of sterile products, particularly aseptically filled products. In 2003, Eli Lilly pioneered the development of a new system for the prevention and containment of crosscontamination during the manufacture of pharmaceutical powders using a specially designed ”fog cart”. This allows the operator to be covered by an exceptionally fine fog of water on exit from a critical area, virtually eliminating the risk of transferring dust traces beyond their proper confines. In 2009, The University of Southampton, UK opened a Nanofabrication Centre containing a clean room with nanofabrication facilities, making it possible to manufacture high-speed and non-volatile ”universal memory” devices for industry that could process information faster than anything achieved with conventional technologies. The Future of Clean RoomsClean room facilities in the United States have been predicted to grow fourfold from a baseline of 1998 to the year 2015, to an estimated 180 million square feet in 2015. The most common applications of clean rooms currently are in the manufacture of semiconductor and other electronic components, as well as in the pharmaceutical and biotechnology industries. In addition to these traditional applications, clean room technology has more recently been applied to micro- and nano-system processes, and this looks certain to be an area of growth in coming years. The development of clean room technology is likely to continue to be driven by certain key factors including the increasingly technical use of exotic physical and biological phenomena, the central role of increasingly fine structures, the creation and use of materials of the highest purity, and the increasingly broad-based utilization of biotechnology. Given the scale of these challenges, clean room technology looks set to remain indispensable to production in coming years.
Please revisit our page regularly! We will be updating our website monthly to keep you up to speed with GMP contamination control in the Pharmaceutical, Medical Device, Biologics, Surgical Device and manufacturing industries.