Pharmaceutical and biotech manufacturers are embracing disposable one-use systems for aseptic filling and capping to cut costs and improve efficiencies, all while meeting strict FDA requirements.

By Sarah Fister Gale

Experts in the pharmaceutical and biotechnology industries are the first to admit that they are not trendsetters when it comes to implementing new technologies. While electronics and semiconductor manufacturers are constantly shrinking geometries and implementing smaller, more cost-effective tools to improve their yields, pharmaceutical experts embrace caution when it comes to innovation.

That caution is prudent in a world where mistakes can cost lives; however, it can also lead to missed opportunities. It takes decades for these industries to adopt new technologies, even when the benefits are proven, creating an environment that is last to take advantage of cutting-edge technologies.

“The industry is somewhat fearful of change, and regulations breed conservatism,” notes Jim Akers, president of Akers Kennedy and Associates, a technical consultancy for the biological and pharmaceutical industry based in Kansas City, MO. “While many people believe that the pharmaceutical industry has the most advanced aseptic processing in the world, they never look outside their world at what other industries are doing. In reality the industry has not kept pace.”

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From purified bulk drug substance to sterile finished product, routine sampling and testing throughout the process ensures a quality end result.

By John Dobiecki and Alex Mello, Microtest Laboratories

Biopharmaceutical manufacturing is the manufacture of protein-based therapies, which include recombinant proteins, monoclonal antibodies, and vaccines, to name a few. With such an extensive repertoire of products, there are many aspects of testing specific to the type of product being assessed. However, there are typical tests that are universal for all these types of products, in addition to traditional synthetic pharmaceuticals (small molecules), that are performed during the manufacturing process.

This article will discuss the typical routine sampling and testing requirements associated with the aseptic processing of a biopharmaceutical from the perspective of a contract aseptic manufacturer. Specifically, the focus will be on what many consider the most critical part of a biological drug product’s manufacturing lifecycle: going from the purified bulk drug substance to the sterile final drug product.

While it’s a given that no two products and processes are alike, the approach described herein provides a good general basis for establishing the testing “where and when” (and in some instances the “why”) for manufacturing formulation and fill/finish activities. While the focus is on processing of biologics, this approach is also applicable for the most part to small-molecule drug product formulation and fill/finish.

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Image analysis methods are compared for detecting particulates

By Monique Dallaire, Clemex Technologies inc.

The quantitative determination of particulate contamination is of prime importance for assessment of cleanliness in various environments from air in cleanrooms to hydraulic fluids in mechanical components.

Manufacturers and quality control labs are finding it increasingly essential to guarantee the purity and uncontaminated state of components and fluids. Diverse industries depend on particle analysis measurements that are both reliable and reproducible. Information this critical must be delivered through proper documentation that is customized to the specific requirements of the internal audience and to industry standards; in this application the ISO 4407 standard was used.

The analysis process of paper filter residue is simple: Fluids, such as oils or solvents, are filtered through a circular membrane. The collected residue is caught by the filter. One method commonly utilized to observe particulate contamination is counting and measuring particulates collected on filters using optical microscopy. In quality control laboratories, automated image analysis allows the user to save time and money as well as eliminate subjectivity due to fatigue. The challenge of automated image analysis is detecting particles of different reflectivity and fibers whose length exceeds the field of view, within a reasonable amount of time.

Once the particles and fibers are detected accurately, the particulate contaminants are separated from the fibers and are classified by size and/or color.

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Dear John:

First let me thank you for the opportunity to comment on your editorial, but let me also emphasize that this response is from me as an individual and not as the chair of the various nanotech standards committees that I have the honour to serve.

I really cannot comment on the documents to which you refer in your first two paragraphs as I am not familiar with them and certainly do not have time to study them in detail. However, it is my understanding that the US regulatory system is based largely on a need for demonstrable harm prior to regulatory control, rather than the European system that enshrines the “precautionary principle,” though this term has a rather specific meaning that is often misinterpreted to mean “proven safety prior to permission to use” by certain groups.

Having said this, I believe that both regulatory systems do have overarching requirements regarding the essential safety of products, though the onus to demonstrate that this is not the case falls on different shoulders depending on which side of the Atlantic one resides.

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Compiled by Carrie Meadows

Maintaining clean critical environments starts from the ground up with these flooring and work-area mat products.

Mats custom manufactured to order

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Connecticut Clean Room Corp. (CCRC) provides cleanroom PolyTack entrance and message mats. CCRC developed the first seamless, one-piece PolyTack entrance mat in 1979. Made-to-order mats allow CCRC the flexibility to produce a variety of sizes and messages depending on customer needs. The company also has an assortment of mat frames for those applications where mats cannot be adhered to the floor. Industries using these mats include pharmaceutical, high-tech, industrial, and others. Ask about BEE SMART information for customizing mats and many other products. To receive a catalog or for information on BEE SMART, call (860) 589-0049.

Connecticut Clean Room Corp.
Bristol, CT
www.ctcleanroom.com

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Compiled by Carrie Meadows

HCl gas purifiers

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Pall has recently added new HCl gas purifier assemblies to its line of purification products. These purifiers, which incorporate the company’s new HCLP purification medium, have been successfully installed in a variety of applications including bulk delivery systems, gas cabinets, and Epi-CVD equipment. The new medium contains a reactive metal on an inorganic substrate. It can remove moisture to <15 ppb in HCl service at ambient temperature. The ability of the purifier to operate at ambient temperature eliminates the need for a heat source, thereby lowering the cost of ownership for the process owner. The HCLP medium is available in all standard purifier assembly configurations for process flow rates up to 1,000 standard liters per minute (slpm).

Pall Corp.
East Hills NY
www.pall.com

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By Sarah Fister Gale

One visit to Peanut Corp. of America’s (PCA) facilities would have raised red flags for any food manufacturer who is even modestly aware of food safety. The Chicago Tribune cited former workers at the Blakely, GA peanut-processing plant who’d witnessed leaking roofs and mice crawling in the peanuts, and a recent FDA inspection report that noted the presence of roaches, mold, and dirty utensils used in food preparation.

The result of PCA’s flagrant lack of food safety protocol was a nationwide Salmonella outbreak that sickened thousands of people in 43 states, left at least eight people dead, and caused the recall of more than 1,000 well-known brand name products that contained peanut butter or peanut paste manufactured by PCA.

People began reporting illnesses in October and by early January the CDC had confirmed Salmonella contamination in several lots of King Nut brand creamy peanut butter, all manufactured by the PCA facility. Because the plant operated as a source of ingredients for final products, the outbreak affected dozens of major brand products including ice cream, cookies, sports bars, packaged meals, cakes, pies, and snack foods.

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By Hank Hogan

This isn’t the best of times for chipmakers, and even the biggest names are feeling the effects. Intel (Santa Clara, CA) announced early this year a halt to production at five older factories, one of which was the company’s last major manufacturing facility left in Silicon Valley. Given that, some might question the timing of the late January launch of the new Environment, Safety & Health (ESH) Technology Center by the International SEMATECH Manufacturing Consortium (ISMI; Austin, TX).

But Scott Kramer, vice president of manufacturing technology at SEMATECH, says delay isn’t an option. “These issues that we’re dealing with in manufacturing sustainability are urgent issues and they are current issues. They will not wait.”

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