According to Lorie Croston, global product manager, labware and specialty plastics, Thermo Fisher Scientific, Middletown, Va, an important issue regarding the use of plastics/consumables in clinical labs is that of cost savings leading to inferior products.

Croston says that one trend among labs is to try to save money. Many plastic lab products are not of high enough quality, primarily because they’re manufactured from low-quality resins that may contain additives that leach into samples or reagents and contaminate them. Lubricants may be added to plastics to make them easier to mold, but if used in more than trace amounts they can leach out, ruining lab reagents and compromising test results. Some plastic additives can also be toxic to cells and may compromise microbiological tests and cell culture success.

Thermo Fisher’s Nalgene® Economy Bottles are available in either rigid high-density polyethylene (HDPE) or autoclavable polypropylene copolymer (PPCO). Both are excellent for room-temperature, refrigerated, and freezer use, and feature the Nalgene linerless closure system for leakproof performance. Technical support is available to assist in selecting the right resin for applications, ensuring optimal performance, she explains.

Nalgene Economy Bottles are lightweight versions of the original Nalgene Lab Quality Bottles. These bottles are suitable for light-duty, general-purpose laboratory applications such as containing samples and daily working solutions like buffers and bench reagents. The Economy Bottles are manufactured, assembled, and conveniently packaged in an ISO-certified facility from biologically tested and certified resins. Lot-specific product certificates of compliance are available for quality assurance.

High-Quality Plastics Mean No Contaminant Worries

Thermo Fisher uses only high-quality plastic, so customers don’t have to worry about contaminants leaching into samples. “You have to buy from reputable sources that meet production standards,” Croston says. Thermo Fisher’s manufacturing facility is ISO 134852003 certified. The company does make some of its own medical devices. Bottles are not registered medical devices, but the ones it sells are still manufactured to those standards.

“These are state-of-the-art and far above any of our competitors. It’s important not to cut costs too much,” she says. “But with Nalgene Economy bottles, you can have a high-quality Nalgene bottle and stay within a budget, too.” Croston adds that it’s a must to work with a reputable company and know where the products are coming from even for general lab use.

Clinical labs use such plastic products as loops and needles, Petri dishes, and, of course, bottles for collecting and storing samples, reagents, and other fluids, Croston says. “Our product, the Thermo Scientific Nalgene Economy plastic bottle, is very economical, and it is leak-proof and light-weight,” she explains.

It’s also more flexible and very suitable for lab use in containing buffers, stains, etc. These bottles are for light-duty laboratory applications such as containing samples and daily working solutions like buffers and bench reagents. Guaranteed leak-proof, the bottles offer exceptional durability and are chemically resistant.

Thermo Fisher Scientific recently announced the availability of the new Thermo Scientific Aspire™ Protein A, Protein G, and IMAC Cobalt Chromatography Tips. Aspire proteomic tips are 1-mL pipette tips embedded with various Thermo Scientific Pierce resins, including immobilized Protein A Plus, Protein G Plus, and HisPur Cobalt resins. These pipette tips utilize color-coded purification workflows and allow accelerated sample preparation without compromising yield or purity. Up to eight samples can be processed in parallel within 20 minutes without the need for centrifugation. The Aspire chromatography tips allow for high-quality, cost-effective sample preparations in less time.

Diane Ban, product manager, preanalytics, Greiner Bio-One, Monroe, NC, says that Greiner Bio-One plastic products made in the United States, Austria, Hungary, Brazil, and Thailand are produced to the same quality specifications.

Currently, she says, “The industry is focusing on safety from exposure to blood-borne pathogens and needlesticks. The next generation of products will focus on automatic safety mechanisms that incorporate the activation of the safety device with the venipuncture procedure. In other words, the engagement of the safety device will not have to rely on the user to take another step to activate the safety mechanism. The needle will shield itself as part of the venipuncture process. Greiner has several of these ‘automatic’ devices under development.”

Greiner’s recently launched items for blood collection include the VACUETTE® QUICKSHIELD Complete Plus, which combines the safety of the QUICKSHIELD Safety Tube Holder with the innovation of the VISIO PLUS Multi-Sample Needle. The multi-sample needle has a translucent plastic hub/view window that provides visual “flash” confirmation that the venipuncture is successful. The safety shield is attached directly to the holder and is activated by pressing on a solid surface. Hands are always behind the needle, and the needle is locked into the shield after activation. QUICKSHIELD Complete Plus is individually wrapped and sterilized to ensure the ultimate hygienic product delivery, and the unit is fully assembled to save time.

Unique Molding Processes for Specific Applications

According to Norman Sharples, executive vice president, Copan Diagnostics Inc, Murietta, Calif, Copan is unique because it has three different types of plastic molding operations to produce different types of laboratory consumables. The types of plastic molding used at Copan are: (1) blow molding, (2) injection molding, and (3) two-step injection molding.

Blow molding is used to produce Pasteur pipettes and Copan’s traditional Transystem media tubes, explains Gabriela Powers, the company’s global marketing manager.

Copan pipette

She says Copan offers a broad line of pipettes, including graduated pipettes, narrow stem pipettes, blood bank pipettes, fine tip pipettes, paddle pipettes, general purpose pipettes, extra large pipettes, and a no drop count pipette for transferring and dispensing liquids safely in all types of laboratories (blood bank, hematology, bacteriology, urinalysis, etc), including point-of-care facilities. The most commonly used pipettes are the 1-mL, 3-mL, and blood bank pipettes.

Copan now produces pipettes on two continents because this type of consumable must be produced close to the point of consumption to ensure prompt supply, Powers says. Cost competitiveness and high quality are imperative in this type of consumable, and Copan achieves this by utilizing high technology, quality raw materials, 100% recycling, and minimal human intervention, Powers says.

Injection molding, Sharples notes, is used for manufacturing tubes, caps, and applicator sticks for Copan’s traditional line of transport systems, but also for manufacturing laboratory consumables like disposable inoculating loops, needles, and spreaders. Copan manufactures disposable inoculating loops in a unique choice of two different types of plastic material consistency—soft (or Flexible Plastic) and Hard (or Rigid Plastic)—to suit different lab applications and preferences of microbiologists.

Copan produces 1-µL and 10-µL loops using soft, flexible, low-density plastic and another parallel product line from hard, rigid, high-density plastic. This choice means that laboratories can obtain both loop styles from one source instead of buying “hard” loops from one manufacturer and “soft” loops from another.

Copan plastic disposable loops are very accurate and comply within ASM’s +/- 20% tolerance limits, and every box of loops is delivered with a certificate of calibration. “To be low-cost is important, but quality and accuracy cannot be compromised. If our 1-µL loop were to deliver 2 µL, the results would be false. If our 10-µL loop were to deliver 5 µL, that is also a misleading result,” Sharples notes.

Inoculating loops are an important tool used in large numbers in clinical microbiology for a multitude of different tasks. Some of these tasks involve the tedious planting and streaking of many hundreds of urine specimens per day or the careful selection and teasing out of suitable material for culture within tenacious samples like sputum, pus, tissue, or feces. To cover all these different tasks, microbiologists normally have to maintain an inventory of more than one style of loop.

Hard plastic loop material is advantageous when selecting material for culture from within a clinical specimen, while softer loop material is better suited to high-volume repeated planting of fluid specimens. One fact is certain: There is no single type of plastic loop that is multipurpose and covers all applications, Sharples says.

Technologists also have strong personal preferences to which style they find most efficient and suited to particular jobs. Hard loops work better for scraping or harvesting organisms from a slant or plate and for making stab cultures. Different tasks and different preferences means that most laboratories need to stock two types of loops—rigid plastic and soft, flexible plastic styles.

Traditionally, plastic loop manufacturers made either rigid loops or flexible loops because the mold design and system for injection blow molding worked to produce only one type of product—either a hard, rigid loop or a soft, flexible loop. Copan was the first manufacturer to develop molds and injection equipment that is capable of handling different plastic raw material mixtures enabling the manufacture of both, rigid or flexible, plastic inoculating loops using the same mold, he says.

Powers says that two-step injection molding is used to manufacture the patent-pending PnR caps, comprising of a HDPE cap and Thermoelastomer pierce-able membrane. This two-step process is quite sophisticated, and the PnR cap design is unique to Copan, as well as a good example of innovation, she says.

Copan pierceable cover

“Copan PnR cap, an acronym for Pierce-able and Re-sealable, is an example of how we listen and are responsive to customer needs. Copan is working, in collaboration with molecular assay kit manufacturers, to bring this cap to market. You can imagine the repetitive stress on uncapping and recapping thousands of specimen tubes per day in microbiology if you did a lot of CT/GC testing or any liquid sample testing,” she says.

This new plastic PnR cap works as follows:

  1. The PnR cap arrives sealed (with a foil seal), which prevents any evaporation.
  2. The automatic pipettor pierces through the foil seal, and it breaks the membrane valve along a “micro-perforated” line.
  3. Then the automatic pipettor enters the tube. The pressure must equilibrate immediately. Otherwise, the volume uptake is hindered or compromised by the pressure.
  4. The liquid is taken up, and then the automatic pipettor exits.
  5. The PnR cap’s membrane valve must reconstitute within a few seconds to make the tube leakproof.

Thus, the PnR cap, when used with an automatic pipettor, enables automatic opening, sampling, and reclosing.

Sharples says that Copan plastic molding operations bring three benefits: (1) key plastic consumable products are produced and ready for sale, like pipettes and loops, using different plastic molding techniques; (2) Copan is vertically integrated, and it makes in-house all plastic components needed to turn raw materials into finished goods and keeping in mind high-quality standards that customers expect; and (3) it can make custom components for diagnostic kit manufacturers.

Because of Copan’s high scientific investment, it is continually on the lookout for innovative solutions to improve the analytics or preanalytics, so it has broad plastic molding capability/know-how, with operations in two continents. “We are investing in growing operations, and we have the science and technology in-house to respond to customer needs and bring new products to the market,” Sharples says.

Gary Tufel is a contributing writer for CLP.