Pharmaceutical

GMP Compliant Monitoring of Pharmaceutical Plant Compressed Air Systems

By Wolfgang Rudloff, gmp-experts and Simon Gleissner, SUTO iTEC

This article is intended to show the relationships between risks and specifications, opportunities and responsibility in validation, and in particular, the use of modern and calibrated measurement technology in the sample chain.

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20 Years of Case Studies: Plants Sharing Best Practices

Edited by Troy Dreier, Senior Editor, Compressed Air Best Practices® 

For 20 years, Compressed Air Best Practices® Magazine has published articles focused on helping manufacturers reduce power demand, lower water consumption, and improve the performance of compressed air, cooling, blower and industrial vacuum systems. In this article, we highlight a sampling of those stories across the following industries: Plastics and Packaging Food and Beverage Automotive and Transportation Cement, Building Materials, and Mining Metals, Pulp, and Paper Pharmaceuticals, Healthcare, and Research Wastewater Treatment 
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Sterile Compressed Air Filters Remove Bacteria

By Peter Gray, Air Solutions Canada

When compressed air comes into direct contact with a product, many applications believe their “standard” particulate and coalescing oil-removing filters, installed either side of a compressed air dryer, are sufficient to protect the downstream processes. Strangely enough, the removal of bacteria is often overlooked, despite this level of filtration being readily available, easy to procure, install and maintain.
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Standardization of Automation Components Pays Off at New Biotest AG Plasma Fractionation Plant

By Ralf Baumann

Blood plasma is an indispensable resource in the production of life-saving medicines. It is also in high demand on global markets. To make more efficient use of this valuable commodity, Biotest AG developed a new large-scale production plant in Dreieich, Germany, for plasma fractionation capable of obtaining five instead of the previous three products from a single liter of blood plasma. As part of its strategy, Biotest AG worked with Festo to standardize automation components used at the plant, resulting in simplified installation and maintenance.
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How to Implement Aseptic Technique in Microbiological Compressed Air Testing

By Trace Analytics

In modern and industrial work settings, people spend more than 90% of their time in enclosed spaces, such as warehouses, office buildings and factories. In most indoor environments, the air contains a variety of chemical and microbial particles, commonly defined as indoor pollutants, which can severely affect human health and product quality (1). Industries like food and beverage, medical devices and pharmaceutical manufacturers rely on their scheduled compliance testing to confirm the presence or absence of issues in workflow pipelines that are detrimental to the daily output and safety of the product.
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Microbial Testing and Compressed Air Standard ISO 8573-7

By Maria Sandoval, Microbiologist, Trace Analytics

This article will focus on ISO8573-7 normative test methods and analysis for viable microbiological contaminants and how it can be fundamentally utilized in compressed air microbial monitoring plans. The quality of the compressed air must be monitored periodically to fulfill national and international standards. ISO 8573 is an available standard addressing compressed air quality. It consists of nine parts that address purity classes, specifications, and procedures. ISO 8573-7:2003, can be utilized across all industries’ compressed air microbial monitoring plans. It contains both informative and normative procedures but lacks any tested compressed air microbial specifications regarding colony enumeration limits for microbial plate counts.
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Instrument Air and Breathing Air at a Pharmaceutical Plant

By Ron Marshall, Marshall Compressed Air Consulting

A pharmaceutical plant, has had a compressed air assessment performed on two plant systems.  The studies uncovered poor compressed air production efficiency, high air dryer loss, and problems with high flow compressed air uses negatively affecting plant pressure. The plant implemented energy efficiency measures, on the two compressed air systems, saving 46 and 64 percent in energy costs respectively.
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Fine Tuning Oil-Free Air Compressors and Purification at a Pharmaceutical Plant

By Don van Ormer, APenergy

A pharmaceutical product manufacturer spends an estimated \$137,443 annually on electricity to operate the oil-free air compressors in its compressed air system. The compressed air system operates well and is providing the level of purification required.  Our team visited the plant and identified a group of projects which could reduce compressed air demand and reduce energy costs by \$42,248 – or 31% of current use.
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Pharmaceutical Deploys Flow-based System to Control Centrifugal and Screw Air Compressors

By Tim Dugan, P.E. President, Compression Engineering Corporation

A large pharmaceutical company needed huge flow rates of 30 psig air to aerate multiple fermentation processes which create food-grade materials.  Flow could vary from about 12,000 scfm to 35,000 scfm.  There were a variety of batch processes, mostly running independently.  An hour-by-hour schedule for anticipated air flow is developed every afternoon for the next day.  Based on that schedule, the boiler operators run the air compressors that can handle the load range for the whole day. In reality, the peak flow can be higher than anticipated.
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NMR Spectroscopy Lab Requires a -112°F Dew Point and Pure Nitrogen

By Rod Smith, Compressed Air Best Practices® Magazine

 

Compressed Air Best Practices® Magazine interviewed Mr. Warwick Rampley, the National Sales Manager for Sydney (Australia) based, Basil V.R. Greatrex Pty Ltd. It’s not every day one is asked to deliver a system able to provide both a reliable compressed air dew point of -80°C (-112°F) and high purity nitrogen.  We work with some excellent technology suppliers and have engineered a rather interesting system.  Although our firm was founded in 1919, this application is one of the most demanding we’ve encountered. Basil V.R. Greatrex is a unique company as we focus only on compressed air measurement, compressed air quality and compressed air efficiency.
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Comparison of the Compressed Air Microbial Testing Unit to a Standard Method of Bioaerosol Sampling

By Lynne Landsborough Ph.D.

Compressed air is used in a number of processes in the food industry. It is used as an ingredient in whipped products such as ice cream, to slice or cut soft products and to open packages before filling of product. Currently, food manufacturers are under pressure to validate the safety of all ingredients or processes for regulatory compliance, but unfortunately, there is currently no standard method to evaluate the microbial content of compressed air.
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Air Quality in the Pharmaceutical Industry

By Chris Kelsey

The United States accounts for roughly half of the global pharmaceutical market. This certainly keeps the Food and Drug Administration (FDA) busy in its oversight of pharmaceutical safety and effectiveness, including with the production processes. As the pharmaceutical industry has grown, so too has its utilization of compressed air for breathing air, operation of equipment and instrument air.
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A View From Southeast Asia. A Pharmaceutical System Assessment

By JoGar Energy & Utility Services

We conducted a comprehensive compressed air system assessment. Opportunities to improve the system were found in the main piping system, in reducing pressure losses in the mold machine piping, and with the high ambient temperatures found in the compressor room. We estimated energy savings of 403,500 kWh per year for a power savings of \$65,000 per year. The total projects costs were \$48,000 for a simple ROI of nine (9) months.
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Three Demand-Side Projects at a Pharmaceutical Plant

By Hank Van Ormer, Air Power USA

This pharmaceutical plant spends \$265,100 annually on energy to operate the compressed air system at their facility. This figure will increase as electric rates are projected to be raised from their current average of 7.7 cents /kWh. The set of projects identified in the compressed air system assessment could reduce these energy costs by \$139,300 per year (52%).
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A Pharmaceutical Compressed Air System Audit

By SMC USA

This West Coast pharmaceutical facility has a very clean and organized compressed air system. All equipments is in good working order in the compressor room. The compressor room itself is very clean and well ventilated. The management requested a compressed air system audit for two reasons:
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Talking Dewpoint

Compressed Air Best Practices® discussed dewpoint with Steve Jiroutek (Application Engineer) of Vaisala Inc.

Dewpoint is defined as the temperature to which a gas (e.g. air) must be cooled, at constant pressure, for water vapor to begin to condense to liquid water. In other words, when the dewpoint temperature has been reached, the gas is fully saturated with water vapor.
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Reducing Packaging Cycle Times

By Phil O’Neill, Standard Products Manager, Bosch Rexroth Pneumatics

Swiss brush company Ebnat-Kappel uses non contact transfer technology from Bosch Rexroth to automate a problematic section of its packaging production process.
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Roxane Laboratories’ System Assessment

By Hank Van Ormer, Air Power USA

Roxane Laboratories, Inc., a subsidiary of Boehringer Ingelheim Corporation located in Columbus, Ohio, created a world-class air system that generated \$61,314 per year in electrical energy cost savings (1,156,868 kWh), improved productivity and quality, and allowed the successful completion of a significant plant expansion.
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Sustainability at Millipore

By Rod Smith, Compressed Air Best Practices

Compressed Air Best Practices interviewed Paul Lukitsch.  Mr. Lukitsch is the Regional Facilities & Energy Manager for Millipore Corporation.
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ISO 8573.1 – Contaminants and Purity Classes

By Dan Ryan, Division Engineering Manager, Parker Hannifin Corporation

Industry standards serve a very important purpose for the end users of compressed air equipment.  If the standards are well written, they can help to promote the equipment that they govern, as long as the equipment manufacturers properly apply and promote the standards.
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