
 The redesigned ViscoMist spray nozzle from Lechler (St. Charles, IL) incorporates features that reduce the chance for fluid to drip when the nozzle is not in use. The device’s new O-rings provide a better seal than before when the nozzle is shut off. In addition, the nozzle’s shut-off needle has been improved. 

Lechler has slightly extended the ViscoMist nozzle’s liquid orifice upward to eliminate the bearding effect. The orifice is completely encircled by a pneumatic port that helps blow particles away from this area without interfering with the orifice’s ability to create the shape of the spray pattern.

One available model of the nozzle contains three ports for incoming air. One port controls the signal air and turns the nozzle on and off. Another port controls atomizing (i.e., droplet size), and the third controls the shape of the spray. Users can adjust either of the latter two parameters without affecting the other.

Thermo Fisher Scientific 
 Liquid handler offers versatility


Thermo Fisher Scientific’s (Waltham, MA) Versette liquid handler offers 19 interchangeable pipetting-head options ranging from one to 384 channels. The unit is compatible with both disposable and fixed-tip pipetting heads, and its total volume range is 0.1–1250 µL. The device’s ClipTips create a binary seal and fasten securely to pipette heads. Low insertion and ejection force is required, so the pipetting head and instrument components experience little wear.

The handler’s D.A.R.T. tips form a secure surface seal against the underside of the pipetting heads. All D.A.R.T. tips are evenly positioned on three axes, thus allowing optimal positioning within labware wells for liquid-handling procedures. This design helps to ensure accurate and precise pipetting. The Versette unit offers two stage capacity options to provide scalability. The two- and six-position stages are easy to swap and enable stand-alone and robot-friendly use.

Articles

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the August 2010 edition from Lechler and Thermo Fisher Scientific.

August 2010 Editor's Picks: Products from Lechler and Thermo Fisher Scientific

Changing or upgrading cleanroom gloves requires time and due consideration. A good decision could improve employee satisfaction and product yields, but a bad decision could necessitate millions of dollars worth of rework, recalls, and rejects if the gloves don’t perform as expected. Personnel should consider various criteria to choose the best glove for their cleanroom.


Cleanroom gloves typically are made from vinyl, natural rubber latex, or nitrile. Vinyl dissipates static and is considered clean and inexpensive. Vinyl gloves retain heat, however, and transmit moisture vapor poorly.

Natural rubber latex has the best cost–performance ratio of any material available. It is durable and easy to manufacture, but does not dissipate static. Also, some people have allergies to the proteins found in natural latex that can result in painful rashes.

Nitrile offers good puncture resistance and exhibits broader chemical resistance, especially to solvents, than natural rubber latex does. Unlike natural rubber latex, nitrile dissipates static well and does not cause allergic reactions. Nitrile gloves also are becoming more affordable.

A glove’s material can influence its comfort dramatically. Latex gloves typically are considered comfortable, but vinyl gloves tend to be uncomfortable because of their rigidity. Nitrile gloves are becoming more comfortable, and some suppliers are using new nitrile-based production technologies to combine the sensitivity of latex with the protection of nitrile.


Cleanroom gloves should exhibit various performance factors (see Table I). For example, a glove’s particle and extractable counts should match the class of the cleanroom. The Institute of Environmental Sciences and Technology’s RP-CC005.3 standard provides material specifications and procedures for evaluating the cleanliness of cleanroom gloves. It also helps users choose the proper glove type and test method according to their applications.

Gloves also should comply with standards from organizations such as the American Society for Testing and Materials (ASTM) and the US Pharmacopeia. Some suppliers exceed the minimum performance standards set by these organizations. 

Gloves must withstand not only tasks within the cleanroom, but also the gowning process. They must not tear so that operators do not have to leave the cleanroom to regown. Barrier integrity (i.e., freedom from pinholes) is another critical quality, especially for sterile cleanroom gloves.

If a cleanroom environment is sensitive to static electricity, gloves should be evaluated for their resistance to electrostatic discharge. Gloves also should be evaluated to ensure that they do not contain nonvolatile residue, contamination that is not easily removed from surfaces through evaporation.

Operators should examine the glove’s tack level, too. High-tack gloves sometimes are preferable because they make it easier to hold items. But a slick grip facilitates donning and double-donning, which is common in aseptic environments. Texture can be limited to a glove’s fingertips or can cover its entire surface. Beaded cuffs make gloves easier to grip and pull up during donning.

The gloves’ length also affects their applications. Cleanroom gloves are either 10 or 12 in. from the tip of the middle finger to the cuff. Less stringent environments can accept 10-in. gloves, but 12-in. gloves and gowns are used in more stringent cleanrooms. Personnel can tuck the gown sleeves into longer gloves, thus preventing the sleeves from billowing out and creating a potential contamination concern.

Finally, most cleanroom gloves are designed to protect the sensitive cleanroom environment from contamination by workers, but workers may need protection from chemicals, acids, or other hazards in the environment. Consider a glove’s protective properties during the evaluation.


Shutting down a cleanroom can cost manufacturers as much as $1.5 million per day, so consistently high glove performance is of utmost importance. Gloves should stay within a reasonable range of quality over time, and the glove vendor should ensure lot consistency throughout its manufacturing process.

The acceptable quality level (AQL) refers to the probability of having defective gloves within a lot. The lower the AQL, the lower the probability of defective gloves. ASTM sets an AQL of 2.5, but some glove suppliers exceed that standard to provide gloves with fewer pinholes and, thus, a higher level of barrier protection.

A glove supplier should provide certificates of analysis with particle and extractable counts for each lot of product. Suppliers of sterile gloves should provide trend data, technical specification sheets, and certificates of irradiation. This information sometimes is accessible on suppliers’ websites. Actual data are preferable to average data because they reflect consistency in quality manufacturing.


Cleanroom gloves should be packaged in a cleanroom environment and double-bagged with an additional case liner to ensure cleanliness. The gloves also should be sterilized (e.g., through gamma irradiation) to reduce their potential bioburden. Sterile gloves also should be packaged in high-density polyethylene pouches and wallets that open up for easy aseptic donning.


Many employees have a stake in selecting and qualifying new products to be used in a cleanroom. Production managers, contamination-control personnel, validation engineers, quality-assurance employees, and purchasing workers all should play a role. After a glove is chosen, employees should test three lots of the product before validating it. Once a new glove is approved, personnel should change the standards of practice for the cleanroom to reflect the new glove.

Careful consideration of materials, comfort, performance, operator protection, and industry standards can help manufacturers find the most appropriate glove for their cleanroom application. An informed choice can ensure that a facility manufactures a sterile product, as well as saving it from costly and time-consuming rework.

Carolina Krevolin is a category manager for scientific gloves at Kimberly-Clark Professional, 

Personal protection:
•	CE Marking
 •	89/686/EEC
 •	EN 420:2003.

Process protection:
 •	ISO 14644-1
 •	EC GMP
 •	IEST-RP-CC005.3
 •	LAL test (kinetic turbimetric tech)
 •	Low presterilization bioburden level
 •	Processed to reduce and control DNAse, RNase, and protease. 

Cytotoxic-drug protection:
•	EN374-3-2003
•	ASTM F 739-99 a
•	ASTM 6978-05.

Biohazard protection:
•	EN374-2-2003
•	ISO 16604 Proc. B:2004
•	AQL and inspection level.

Ergonomics:
•	Double-donning application
•	Tactile sensitivity and grip
•	Comfort and fit
•	Wearer health and safety.

Allergenicity:
•	Low in chemical residue
•	Low in protein
•	Low in endotoxin.

In the Mixer

Changing or upgrading cleanroom gloves requires time and due consideration. A good decision could improve employee satisfaction and product yields, but a bad decision could necessitate millions of dollars worth of rework, recalls, and rejects if the gloves don?t perform as expected. Personnel should consider various criteria to choose the best glove for their cleanroom.

Glove Selection for Controlled Environments

A widespread focus on cancer therapies is increasing drugmakers’ interest in highly potent active pharmaceutical ingredients (HPAPIs). To satisfy rising demand, contract manufacturers such as SAFC (St. Louis, MO) have expanded their ability to produce these ingredients. Making these drugs can be costly because the process often requires equipment specialized to achieve containment and extra attention to safety concerns. Pharmaceutical professionals may wonder whether disposable components, which have reduced the cost of some operations, might be appropriate in the manufacture of HPAPIs.

Until recently, disposable components have been uncommon in nonaqueous API manufacturing processes, which often require aggressive solvents that can degrade disposable components. But new polymer materials such as polyvinylidene fluoride (PVDF) are more robust. Meissner Filtration Products uses PVDF as the as the product-contact layer for its FluoroFlex biocontainer portfolio, which is more compatible with solvents such as dimethylacetamide and dichloromethane better than common polyethylene-based biocontainers, according to the company. The FluoroFlex film also is twice as strong as comparable polyethylene films and incorporates a gas-barrier layer to limit oxygen transfer, says Christian Julien, Meissner’s business-development manager.

Disposable components now represent a small share of the equipment that handles HPAPIs, including sterilizing filter capsules, transfer systems, valves, and liquid-handling systems. But in 5 to 10 years, disposable components will account for more than 90% of such equipment, according to Richard Denk, director of the pharmaceutical department at Hecht Technologie. One reason for this rapid growth is that disposable components eliminate the need for the extensive cleaning that HPAPI manufacture requires, especially in multipurpose facilities.


Disposable components’ increasing safety also could prompt more pharmaceutical companies to adopt them. In the near future, single-use equipment will be able to provide an occupational exposure limit (OEL) of less than 1 ng/m3, says Denk.

Currently available disposable components can be just as safe as stainless-steel equipment, provided that risk is assessed before installation. A secondary system usually can mitigate risk, says Hari Floura, president of consulting firm Floura. For example, a flexible-film disposable bag system can be appropriate as an in-process container, but it cannot withstand excessive temperature or pressure. An insulated interface and safety interlocks and controls can protect the bag from exposure to potentially damaging conditions. 

In some ways, disposable components can be considered safer to use for HPAPI production than stainless steel. Operators often handle stainless-steel containment equipment roughly because it appears stable, but this treatment sometimes damages the equipment. Personnel tend to handle disposables with greater care because they seem more delicate, Denk says. Unlike disposable containment valves, stainless-steel mechanical closing systems are subject to wear that may cause unnoticed leaks and expose operators to hazardous substances. And because disposable components do not require disassembly or cleaning, they significantly reduce the risk of operator exposure to process fluid.


The economics of using  disposable  versus stainless components has to take into account several factors. At first glance, disposables may seem to offer a clear cost advantage over stainless-steel equipment, which can be 30–50% more expensive, depending on the necessary OEL level. But even though the initial cost of disposables is low, it can quickly escalate, depending on the rate at which a company uses them. In six months, a facility could easily spend on disposables what it might have paid for a piece of stainless-steel equipment, says Floura. Personnel should undertake a cost–benefit study before implementing disposable components, he adds.

But other factors have to enter the calculation before one can estimate the true cost of one type of equipment over the other. For instance, stainless-steel equipment must be maintained regularly and cleaned through validated procedures that require additional supplies, labor, and associated expenses. In addition, multipurpose facilities must establish the traceability of the materials in their stainless-steel containment equipment. And, compared with disposable components, stainless-steel containment equipment necessitates a large number of documents, inspections, and instructions. These considerations reveal the sometimes-hidden expenses of stainless-steel equipment.

The benefits generally are worth the cost of disposable components, particularly for contract manufacturers, says Floura. Disposable components help enable these companies to change over between products quickly. Contract manufacturers also can demonstrate that they have reduced the potential for cross-contamination more easily when they use dedicated disposable components. And the added operator safety that closed disposable systems provide often outweighs cost considerations.

Pharmaceutical manufacturers are incorporating disposable components into their operations more and more, and newly developed materials are broadening the variety of applications for which these items are appropriate. Disposable components can protect properly trained operators from toxic ingredients as well as stainless-steel equipment can, provided appropriate precautions are taken. These factors, combined with a favorable cost–benefit analysis, make it likely that disposable components will become more widespread in HPAPI-manufacturing operations in the future.

Production Lines

Making highly potent active pharmaceutical ingredients (HPAPIs) can be costly because the process often requires equipment specialized to achieve containment and extra attention to safety concerns. Pharmaceutical professionals may wonder whether disposable components, which have reduced the cost of some operations, might be appropriate in the manufacture of HPAPIs.

Equipment and Processing Report-08-18-2010

August 2010 Editor's Picks: Products from Lechler and Thermo Fisher Scientific

Glove Selection for Controlled Environments

Are Disposable Components Powerful Enough to Manufacture Highly Potent Drugs?