The ability of an instantaneous microbial detection system (IMD-A) to monitor microbial populations in environmental air was evaluated. The IMD-A results were compared with results from conventional environmental air monitoring methods. The comparisons were carried out in controlled microbial barrier test chambers and in cleanroom environments. Additionally, microbial populations in environmental air in an unclassified environment were evaluated using the IMD-A and the all-gas impingement (AGI) method coupled with ScanRDI. In 1-m3 and 150-m3 controlled-barrier test chamber studies the mean recoveries with the IMD-A were equal to or greater than the mean recoveries obtained with the Anderson air sampler at various concentrations. The mean microbial recoveries obtained using the AGI were higher, but in the same order of magnitude, as those recovered by IMD-A.

Hood, suit, faceplate, cover shoes, gloves: these are the necessary items of clothing when operating in A- and B-grade areas. The principal purpose of protective clothing is to minimize the risk of microbiological contamination caused by personnel. Thus, protective garments should not release fibers and must be able to contain particles produced and released by the body.

But how can we ensure that protective garments are not themselves vehicles of contamination? And how can we ensure that cleaning and sterilization processes are effective and do not alter the characteristics of the garments? We attempted to answer these questions, concentrating our attention mainly on glasses (in general, on individual protection devices usually referred to as masks).

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Biopharmaceutical companies around the world use disposable processing equipment for numerous reasons. According to Barres's 3rd Annual Report and Survey on Biopharmaceutical Manufacturing,1 they are to minimize or improve, in order of importance, cross-contamination, cleaning, time-to-start, capital investment, production cycle, and assurance of sterility. The priority varies, of course, according to a drug company's business objectives. For example, vaccine manufacturers regard cleaning and sterility as the most important reasons for adopting this processing model. Contract manufacturing organizations (CMOs) use disposable technologies because they minimize the risks of cross-contamination. Biotechnology manufacturing firms view disposables as a way to reduce capital investment.

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Almost every day, we hear another story about the spread of avian flu and the possibility that it will lead to a pandemic rivaling the disaster of 1918. Responding to this growing fear, the president recently announced a $7.1 billion plan that would include purchase of 20 million doses of vaccine to protect against the current strain of avian flu. The plan also included incentives to develop new production methods, and protection against liability claims so that vaccine makers would add U.S.-based facilities. “If a pandemic strikes, our country must have a surge capacity in place that will allow us to bring a new vaccine online quickly and manufacture enough to immunize every American against the pandemic strain,” said the president. (For more on the White House’s strategy, see my From the Editor commentary on page 12.)

Manufacturing and laboratory efficiency issues have direct effects o­n cash flow, balance sheet, product quality and customer satisfaction. Performance behind the competition—or ahead of it—can dramatically affect shareholder value. Therefore, in the face of ever-challenging profitability and revenue goals, pharmaceutical companies and contract manufacturers alike are striving to improve and enhance their manufacturing and laboratory efficiency. A solid understanding of manufacturing costs and performance metrics among world-class companies is the first step in evaluating a company’s own current practices.

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Partial-filling affinity capillary electrophoresis (PFACE) is a versatile analytical technique to probe bimolecular non-covalent interactions and to estimate binding constants between receptors and ligands. In this article we demonstrate the use of PFACE and two modifications to PFACE: flow-through PFACE and multiple-step ligand injection to examine the binding of D-Ala-D-Ala terminus peptides to vancomycin from Streptomyces orientalis and arylsulphonamides to carbonic anhydrase B.

Production information is part of a company’s intellectual property and is as important as the materials the company produces. Production information must be accurate and available in real time for management to make informed decisions about the product or business, a process that must be completed with the least amount of time and cost.

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Creation and qualification of scale-down models are essential for performing several critical activities that support process validation and commercial manufacturing. As shown in Figure 1, these activities include process characterization and production support studies that are performed to evaluate column and membrane lifetimes, demonstrate clearance of host-cell impurities and viruses, and troubleshoot manufacturing issues. While the underlying fundamentals are relatively the same as those when scaling up, some unique considerations should be taken when scaling unit operations down.1-4 The goal when scaling down is to create a small-scale or lab-scale system that mimics the performance of its large-scale (pilot or manufacturing) counterpart, when both the process parameters are varied within their operating ranges and also when a process parameter deviates outside its operating range.

Purification and analysis of PEGylated protein pharmaceuticals presents many challenges.

The modification of proteins with polyethylene glycol (PEGylation) is an established technology that has many benefits in the biopharmaceutical industry. For instance, modifying proteins with multiple PEGs masks immunogenic sites and prevents neutralizing-antibody formation to certain proteins and therapeutic enzymes.1-3 Due to the amphiphilic nature of polyethylene glycol, PEGylation can also improve the solubility and physical-chemical stability of proteins.2,3 PEGylation can increase the circulating half-life of proteins, especially smaller peptides and proteins, which normally have a rapid glomerular filtration rate and are cleared on the basis of size. PEGs have a high Stokes-radius-to-mass ratio.

Integrate CIP and process piping in the "pencil and eraser" phase or you will have to use "hacksaw and torch" to add it later.

In biopharmaceutical and many pharmaceutical operations, post-production residues are primarily removed by chemical, rather than physical, means. Chemical cleaning is typically the most efficient mechanism for removing in-process material. Chemical cleaning methods rely on fully developed turbulent flow in pipelines and spray devices (often non-rotating sprayballs) in vessels and other processing equipment to supply rinsing and washing solutions to surfaces being cleaned. Cleaning is a mass transfer process that relies on good mixing and strong convection to produce turbulence. Turbulent flow promotes efficient mass transfer and thus is a key factor in optimizing cleaning cycles.

Abstract: The feasibility of using dense gas techniques such as rapid expansion of supercritical solutions (RESS) and aerosol solvent extraction system (ASES) for micronization of pharmaceutical compounds is demonstrated. The chiral nonsteroidal anti-inflammatory racemic ibuprofen is soluble in carbon dioxide at 35°C and pressures above 90 bar. The particle size decreased to less than 2 µm while the degree of crystallinity was slightly decreased when processed by RESS. The dissolution rate of the ibuprofen (a poorly water-soluble compound) was significantly enhanced after processing by RESS. The nonsteroidal anti-inflammatory drug Cu2(indomethacin)4L2(Cu-Indo); (L = dimethylformamide [DMF]), which possessed very low solubility in supercritical CO2, was successfully micronized by ASES at 25°C and 68.9 bar using DMF as the solvent and CO2 as the antisolvent. The concentration of solute dramatically influenced the precipitate characteristics.