By George Miller

As the wheels of Congress start grinding out legislation to protect federally funded biospecimen collections from inadvertent and malicious destruction, practitioners are of two minds about the government involvement.

The House Science and Technology Committee investigations and oversight subcommittee in September questioned officials of the Veterans Administration (VA) Pittsburgh Health Service on the destruction of a collection of Legionella bacteria. The destruction was ordered by Dr. Mona Melhem, associate chief of staff for clinical services in December 2006, just as arrangements were being made to transfer the collection to another facility.

In less than three hours, the 30-year collection was destroyed, according to testimony.

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Since September, the U.S. Food and Drug Administration (FDA) has been investigating possible contaminated milk-based products coming out of China. The FDA is advising consumers not to consume the following products because of possible melamine contamination:

• YILI Brand Sour Milk Drink
• YILI Brand Pure Milk Drink
• Blue Cat Flavored Drinks
• White Rabbit Candies
• Mr. Brown Mandehling Blend Instant Coffee (3-in-1)
• Mr. Brown Arabica Instant Coffee (3-in-1)
• Mr. Brown Blue Mountain Blend Instant Coffee (3-in-1)
• Mr. Brown Caramel Macchiato Instant Coffee (3-in-1)
• Mr. Brown French Vanilla Instant Coffee (3-in-1)
• Mr. Brown Mandheling Blend instant Coffee (2-in-1)
• Mr. Brown Milk Tea (3-in-1)
• Infant formula manufactured in China

FDA is pursuing an investigation into milk and milk-based products from China, such as this TriStar Food Blue Cat flavored drink, due to possible melamine contamination. Photo courtesy of FDA/ TriStar Food Wholesale Co.Click here to enlarge image

It has been reported that a number of infants in China who have consumed Chinese manufactured infant formula are suffering from kidney stones, a condition the agency says is rare in infants. The Chinese manufactured infant formula may be contaminated with melamine. Melamine artificially increases the protein profile of milk and can cause kidney diseases such as those seen in the Chinese infants.

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Buying swabs in bulk at the lowest price may seem like a cost-effective choice, but those little penny-per-use disposable devices can track contamination into a cleanroom, cloud test results, and cause ESD events if they aren’t chosen with care.

By Sarah Fister Gale

Every year, cleanroom operators invest millions of dollars outfitting their facilities with the latest equipment, technology, monitoring devices, and air handling systems. These big picture items get intense scrutiny in the planning phase of new and upgraded facilities because they cost a fortune and are at the core of maintaining a clean and smooth-running manufacturing environment that will achieve optimal yields.

But, as so many cleanroom operators have learned over the years, cleanliness is in the details. A $4 million lithography tool can be taken down by a seemingly inconsequential material, such as a ten cent swab that sheds fibers as it cleans surfaces in the cleanroom. The wrong swab can also contain microscopic contaminants that cloud environmental test results, leave adhesive residues on equipment surfaces when the swab head reacts with harsh chemicals, create electrostatic discharge (ESD), or leave behind materials that can raise alarms in operations that require strict levels of particulate control.

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Direct conductometric TOC analyzer alerts engineers to potentially damaging trihalomethane excursions in pharmaceutical water

By Terry Stange, PhD, and Matthew J. Smith, PhD, Hach Ultra Analytics

Total organic carbon (TOC) analyzers are becoming industry standard for monitoring purified water (PW) and water for injection (WFI) systems. Accuracy and stability are critical parameters for daily process monitoring of water distribution systems. Direct conductometric (DC) technology, self-calibrating conductivity circuits, and dynamic endpoint detection are being used in new-generation instruments to measure on-line TOC. Although the application of membrane conductivity (MC) for TOC measurement emerged in the mid-1980s, this technology was deterred from use in on-line PW and WFI applications due to the inherent instability of membrane-based TOC analyzers. MC-based analyzers suffer from continuous drift and instability owing to the constant change in CO₂ transfer rates across the membrane in real-world, on-line applications. Variations in pH, temperature, membrane fouling, rouging, and dissolved gases (e.g., chlorine) all contribute to variations in CO₂ transfer rates. These variations require frequent calibration of MC-based TOC analyzers compared to DC-based analyzers, which are also simpler to operate and maintain. DC TOC analyzers are based on the assumption that the only conductive species generated during UV oxidation is CO₂–an assumption rarely violated in today’s advanced PW and WFI systems. When water conditions depart from normal ultra-pure water (UPW) levels, DC TOC analyzers can alert facilities engineers to subtle water chemistry changes that are otherwise ignored by MC-based TOC analyzers.

This article lays out the response of a TOC analyzer to hypothetical trihalomethane (THM) excursions in a UPW system. The sensitivity of DC analyzers to the halogen ions created during oxidation of THMs can alert UPW engineers to potential excursions that might harm the water system components or even violate the Environmental Protection Agency’s (EPA’s) requirements for total THMs in water used to manufacture pharmaceutical products. When incoming source water or UPW meets EPA requirements for THM levels, the TOC analyzers studied will never report a false positive TOC value. In the rare occurrence of THM excursions, the analyzer becomes more than just a TOC analyzer–it also becomes a THM event monitor.

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Many months ago, when we first started talking about the concept and prospect of hosting a “virtual” conference and exhibition, I have to admit I was a little skeptical about how realistic a possibility it actually was. I certainly don’t consider myself a novice to the power of the Internet (I still have my lifetime charter membership to AOL, after all), but I’m also pretty aware of the annoying shortcomings that can pop up and the potential pitfalls that remain, particularly with live events, virtual or not.

Now, however, I’m happy to tell you it’s the real deal. The totally virtual “CleanRooms Worldwide eVent” was–by every account I’ve heard so far, anyway–a great success. Held on October 21 from 8:00 a.m. to 6:00 p.m. Central time, the show brought together visitors from a host of industries and from countries all over the world. It would simply not be possible to accomplish this feat in any other way with a single-day, single-location, real-world event.

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Compiled by Carrie Meadows

Cleaning and disinfecting products are a vital part of ensuring that a clean environment is sterile and contaminant-free. But the type of clean space in question and the level of cleanliness that must be maintained will determine which products will accommodate your specific needs. This month’s spotlight offers a selection of cleaning and disinfecting technologies to keep your critical environment operating at peak cleanliness levels.

Cleaning and disinfection includes biodegradable option

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Connecticut Clean Room Corp. carries an assortment of cleaners and detergents ranging from general-purpose cleaning to the most critical environments. The company offers CR-2, a multi-purpose biodegradable cleaner, as well as a full line of cleaners and detergents for MicroNova such as Nova Clean, Mega Clean, and NovaHol. CCRC has added Accel TB ready-to-use disinfectant to its lineup of cleaning and disinfection solutions. CCRC can assist customers in selecting the right product for any critical environment. To receive a catalog or for information, call (860) 589-0049 and ask the Customer Care Team for more details.

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

Advanced hydrogen peroxide-based disinfectant

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An EPA-registered intermediate-level disinfectant, Contec’s Accel TB is safe and fast acting with a broad-spectrum kill. It is based on accelerated hydrogen peroxide technology (AHP), a synergistic blend of commonly used, safe ingredients that, when combined with low levels of hydrogen peroxide, increase its germicidal potency and cleaning performance. The ready-to-use disinfectant is compatible with many common materials, including 316 and 304 stainless steel, natural and silicone rubber, and most plastics. Accel TB is suitable for use on environmental surfaces in pharmaceutical cleanrooms, compounding pharmacies, labs, and other GMP facilities where short contact time is beneficial. The solution is available in 32 oz. pour bottles, as well as 1- and 5-gal containers. Trigger sprayers are also available. To request a free trial or to learn more about this product, e-mail [email protected].

Contec, Inc.
Spartanburg, SC
www.contecinc.com

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Compiled by Carrie Meadows

Leak-free PFA fittings

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Immediately available is a line of Pureloc® PFA fluoropolymer compression fittings in a dozen styles. Targeted for mating with fluoropolymer tubing, the fittings are used in clean applications such as semiconductor, food and beverage, pharmaceutical, chemical, medical and biomedical, laboratory, and chromatography. Made from virgin-grade, chemically inert PFA fluoropolymer, the fittings are suited for pure fluid applications where contamination-free systems are required. Purelocs consist of four precision-made parts (nut, gripper, ferrule, and body) that provide leak-proof connections. The fittings offer see-through construction to ensure proper fitting installation. The nut design has a ridged surface that is easy to grip and tighten. Purelocs may be disassembled and reused, saving purchase and inventory costs.

NewAge® Industries, Inc.
Southampton, PA
www.newageindustries.com/purelcmn.asp

Humidity and micro head sensors

New additions to the Cambridge AccuSense airflow analysis line, a humidity sensor (UHS1000) and micro head airflow and temperature sensor (UAS2000), provide more functionality for airflow and thermal analysis in the ATm²400/USB sensor line. The UAS2000 micro head airflow and temperature sensor uses patented pulse technology; smaller than 0.5 mm, it can record airflow and temperature inside the fins of a heatsink, between tightly spaced components, and in other small locations. The ATm²400 eliminates time-consuming and costly manual data recording and enables simultaneous measurement of air velocity, humidity, airflow, and surface temperatures at 36 locations. All of the data is recorded in real-time and can be analyzed and manipulated using Accutrac®, a Windows-based software package.

Degree Controls Inc.
Milford, NH
www.degreec.com

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By George Miller

Confronting the difficult head-on, Genzyme Corp. has achieved a high-level certification for energy and environmental design in its Framingham, MA R&D facility unveiled in late September.

The $125 million Science Center carries the gold certification from the U.S. Green Building Council’s Leadership in Energy and Environmental Design (LEED) green building rating system. Gold marks the second-highest level available in the system.

The certification encompasses design and construction criteria in site planning, material use, energy, indoor environmental quality, and water management.

The facility is one of only 10 labs to achieve this ratings level, according to company spokesperson Erin Emlock.

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