Umbicut and Tyvek Work Together to Cut Potential for Neonate Infection

Transcription

1 d January 2002 Volume 10, Issue 3 Tyvek A Medical Packaging Newsletter from DuPont Umbicut and Tyvek Work Together to Cut Potential for Neonate Infection In this Issue: Umbicut and Tyvek Work Together to Cut Potential for Neonate Infection Effect of Pinholes on Sterile Barrier Properties La Calhène, Newform, Octapharma and DuPont Tyvek : Closing the Loop on Contamination People on the Move For More Information: North America Call the Customer Information Center at TYVEK Europe Claude Metzdorf Luxembourg Phone: Fax: Japan Ichiro Ikeda Japan Phone: Fax: Asia-Pacific Daniel Lim Phone: Fax: Visit our website For Seminar Series Information, medpkg@usa.dupont.com In the underdeveloped countries of the world, more than 125 million babies are born each year. Of these, approximately 4 million die from complications due to infection contracted during or shortly after their birth. Many, if not most, of these infections are caused by the unsterilized knives or scalpels used to cut the babies umbilical cords. The new Euroband Umbicut ( from Pollak (International) Ltd. was created as an inexpensive solution to this problem. The device offers a number of benefits to physicians and their patients in developed countries, too. A scissors-like sterile device for clamping and cutting a newborn s umbilical cord, Umbicut is the latest creation of the Israeli company that has been producing sterile disposable instruments, kits and trays for more than 20 years. Pollak distributes its wide array of products worldwide. Umbicut also has received an approval for marketing from the U.S. Food and Drug Administration (FDA) and a certificate of authorization from the European Community, issued by the European Competent Authority in the United Kingdom (Amtac Mediqa). In the United States and the European Community, mothers routinely receive oxytocin to shrink the uterus during delivery. If this drug isn t prevented from reaching the newborn through the umbilical cord, the baby s brain development can be adversely affected. Consequently, the World Health Organization (WHO) states that early or relatively early clamping of the umbilical cord is mandatory after the administration of oxytocin. With Umbicut, a physician uses one continuous motion to clamp, seal and cut a newborn s umbilical cord. Two V-shaped clamps hold and seal the cord while a stainless steel blade cuts the cord between them. Time elapsed for the procedure? Just one second. Plus, shields over the instrument s jaws prevent blood from spurting into the user s eyes, reducing the possibility of the physician contracting an infection from the mother or child. continued on page 3 Printed on Tyvek 1085D.

2 Effect of Pinholes on Sterile Barrier Properties By Earl T. Hackett, Jr. Research Associate DuPont Medical Packaging This topic was originally presented at HealthPack For a complete copy of this presentation please visit our website at Editor s Note: Correction: The Regulatory Update of Volume 10 Issue 2 of Tyvek Rx incorrectly referenced the ASTM test method in the following sentence. The next step for this test method is to obtain prototype test units and perform round robin testing in conjunction with ASTM P2.06. It is actually ASTM F2.06. Introduction Over the past 20 years, many studies have been performed to determine the effect of pinholes on the microbial barrier characteristics of various package designs. These studies have been prompted by the proliferation of prepared packaged foods and the increased awareness of the threat of microbial contamination of medical instruments. Tests have been performed using a wide range of protocols and the results have been contradictory. Some laboratory tests have shown that sub-micron holes will allow contamination, while studies of commercial packages with holes larger than 10 µm were found to be free of microbial contamination. 1-7 In cases where small leaks have allowed device contamination, the test protocol has employed very high challenge concentrations and test conditions well beyond the environment a package would see in normal commerce. In these cases, the microorganism may be used as a probe to detect a leak rather than to determine the effect of the leak on the package performance. A variety of techniques are used to assure the integrity of medical packaging. All test methods have a minimum size defect that can be detected. Test methods commonly in use today have size limits in the range of 25 µm to 75 µm diameter, sizes large enough to allow microbial penetration. Unresolved is the question: What is the effect of small leaks, below the limits of detection, on package integrity in the normal commercial environment? To determine the effect of any given leak on package integrity, consideration must be given to the package design, including head space, materials of construction and the characteristics of any breathable membrane. Study Conducted Working to resolve this question, a study was conducted by DuPont and the results were compared to predicted values using equations supplied by Dr. Paul Baron of the Centers for Disease Control. (These equations can be downloaded in Excel spreadsheet form from We know that the probability of a particle penetrating a defect in a package is a function of the particle and defect size as well as the flow rate through the defect. The equations describing particle motion in an air stream were used to estimate the probability of particles penetrating a package defect. These results were then compared to experimental data. The range of pressure differentials experienced during the shipment of sterile devices was examined during the study and the overall significance of pinholes in sterile packaging was evaluated. 2 Comparison of Empirical Predictions With Experimental Data A small set of data was generated two years ago using accurately sized holes drilled in 75-µm thick stainless steel. These steel shims were then glued with the drilled hole centered on a small window at the center of a 10-cm diameter disk of either coated or uncoated Tyvek 1073B. The samples were then placed in a device designed to measure the barrier characteristics of materials at very low pressure differentials. Measurements were first taken on the samples with the hole over the open window and then with the hole sealed with some silicone rubber. Measurements were made over a range of pressures extending to the lower limits of the apparatus. The limiting factor was the presence of particles penetrating the HEPA filters delivering the sweep air. Data collection was terminated when the measured concentration was within one order of magnitude of the background concentration. Tables I through III (see page 5) compare the results of the calculations with actual measured values, normalized to a challenge concentration of 50,000 p/cc and assuming 100% aspiration and no diffusion losses. The predicted concentration took into consideration particles passing through the pinhole, as well as those passing through the barrier material. In most cases, agreement between predicted and observed values is good. On coated samples with 25-µm and 50-µm holes, the predicted particulate penetration was much higher than was experimentally observed. The most likely cause of this disparity is the loss of particles on the surface surrounding the exit of the defect due to toroidal flow. Other possible causes of the discrepancy are the predicted flow through the defect being too high or a higher than predicted particle loss due to diffusion. Further work will be required to identify the source of the discrepancy. Conclusion With improved mechanistic models and data against which they can be verified, it may be possible to predict the resistance of a package to contamination based on its physical characteristics. This would allow packaging engineers to design to a level of package integrity even in the presence of a defect below the detection limit. Editor s Note: The Experiment at a Glance: An aerosol is made to flow through the Tyvek. Then, the particle concentration is measured before it enters the Tyvek and after it exits. The effectiveness of the filtration depends on the flow rate. If there is a significant difference noted when the pinhole is plugged (vs. open), then the pinhole had a significant effect on the barrier characteristics of the sample. The sample was a sheet of Tyvek with a 1/4-inch-diameter hole cut in the center and a piece of stainless steel shim stock sealed over the hole (so that the drilled hole was centered over the hole in the sheet of Tyvek ).

3 Effect of Pinholes on Sterile Barrier Properties Table I. Penetration of 0.5-µm diameter particles through 125-µm holes Sample ID 1 uncoated 2 uncoated 1 coated 2 coated Pressure Differential, cm Water Column Bendtsen Measured Concentration, p/cc* Predicted Concentration, p/cc* Table II. Penetration of 0.5-µm diameter particles through 50-µm holes Sample ID 3 uncoated 4 uncoated 3 coated 4 coated Pressure Differential, cm Water Column Bendtsen Measured Concentration, p/cc* Predicted Concentration, p/cc* Table III. Penetration of 0.5-µm diameter particles through 25-µm holes Sample ID 5 uncoated 6 uncoated 5 coated 6 coated Pressure Differential, cm Water Column Bendtsen Measured Concentration, p/cc* Predicted Concentration, p/cc* * p/cc = particles per cc of aerosol References Willeke and Baron (W&B), Aerosol Measurement, Van Nostrand Reinhold 1993 Hinds, Aerosol Technology, J. Wiley and Sons, Axelson, Cavlin, and Nordstrom. Aseptic integrity and microhole determination of packages by electrolytic conductance measurements. Packaging Technology and Science 3: ; Chen, Harte, Lai, Pestka and Henyoa. Assessment of package integrity using a spray cabinet technique. J. Food Protection 54(8): ; Gilchrist, Rhea, Dickerson and Campbell. A helium leak test for micron-sized holes in canned foods. J. Food Protection 48(10): ; Howard and Duberstein. A case of penetration of 0.2-micron rated membrane filters by bacteria. J. Parenteral Drug Assoc., 34(2):95-102; Lake, Graves, Lesniewski and Anderson. Postprocessing spoilage of low-acid canned foods by mesophilic anaerobic sporeformers. J. Food Protection 48(3): ; Lampi. Retort pouch: The development of a basic packaging concept in today s high technology era. J. Food Process Eng. 4:1-18; McEldowney and Fletcher. The effect of physical and microbiological factors on food container leakage. J. Applied Bacteriology 69: ;

4 Umbicut and Tyvek Work Together to Cut Potential for Neonate Infection continued from front cover In less developed countries where midwives traditionally deliver babies the ease of use of the sterile Umbicut device is especially important. Its identical handles can be gripped by either the left or right hand, and its two identical clamps allow cutting the cord whether the baby is on the right or left. Equally important is the fact that Umbicut can be employed for only its intended use, unlike scalpels or knives. And, it s packaged sterile. These factors are crucial in developing countries where WHO has tracked high rates of neonatal tetanus and cord infection two major causes of infant death. In underdeveloped countries, midwives might use a knife or scalpel that has been used for other purposes and hasn t been sterilized, explained Michael Porat, managing director of Pollak. The babies not only die; they suffer greatly as they die. We believe that it s mandatory to use Tyvek for Umbicut. It may seem to be more expensive, but it s worth it because we provide first-class, safe products. Michael Porat, Managing Director of Pollak To ensure the instrument s sterility, Pollak uses Tyvek brand protective material in the Umbicut rigid peelpack. We believe that it s mandatory to use Tyvek for Umbicut, Porat said. It may seem to be more expensive, but it s worth it because we provide first-class, safe products. In fact, Pollak uses Tyvek 1059B for all of its products. If you re making a rigid pack with paper and something falls on it, the paper can rip or develop a pinhole, Porat said. The package will lose its sterility, and if the damage is small enough, you may not realize it s happened. Over our many years of experience in the medical field, we ve found that Tyvek is the optimal solution for the upper web of our kit packaging, Porat continued. Transparent rigid packs are only safe with a lid of Tyvek because medical-grade paper (even 80 grams) isn t strong enough to withstand puncturing by sharp instruments. Porat reports that Tyvek maintains its strength and integrity during Pollak s sterilization processes. (The company predominantly utilizes ethylene oxide sterilization.) He s also been pleased with the results his company has achieved when printing on Tyvek. It took a bit of getting used to, but we get consistently good results now. According to Porat, Tyvek has definite advantages for end-users, as well. Tyvek peels better and cleaner than paper, he said. That helps further protect our products from contamination. Pollak purchases its Tyvek from SteriPack Medical in Clara County, Offaly, Ireland. Pollak makes everything itself (except Tyvek ) and has mastered backward integrated manufacturing to protect its valuable products, said Garry Moore, managing director of SteriPack. We re happy to service Pollak s needs and continue to help the company develop new packaging ideas. As far as Porat is concerned, any new ideas are bound to include Tyvek. We ve been using Tyvek since before 1980, he stated. We re not even considering an alternative. SteriPack Medical s website is located at Euroband and Umbicut are registered trademarks of Pollak (International) Ltd. 3

5 La Calhène, Newform, Octapharma and DuPont Tyvek : Closing the Loop on Contamination Octapharma AG, a Switzerland-based company that develops, produces and markets high-quality plasma products, was concerned about meeting stringent requirements for product sterility assurance. The company had conventional aseptic filling lines, with critical areas protected by a laminar flow. To increase the security of the aseptic manufacturing processes, it had even equipped its filling lines with a barrier made out of a stainless steel cage, with walls and doors made out of glass. However, because operators used sterile scalpels to open the bags of Tyvek containing the sterilized stoppers, contamination at this juncture was a potential problem. And, the remote possibility of contamination during the transfer of sterile stoppers to the sorter remained a concern. A combination of the DPTE double door transfer system from La Calhène and Newform s new Ultraclean steam-sterilizable CleanConnect DPTEBetabag made with DuPont Tyvek brand protective material resolved both issues. With the DPTE system, items can be introduced to, and removed from, the filling zone with constant protection of the product. Consequently, bulk autoclaved components can be introduced to feed filling lines without breaking containment. Introduced in the late 1960s, the original autoclavable DPTE system used a stainless steel cylinder with a hydrophobic membrane filter that allowed vacuum to be formed and steam to penetrate the cylinder. But the cylinder could be heavy and took up a great deal of space. The CleanConnect DPTEBetabag made with Tyvek has made the system more convenient and easier to use. The bag was designed through the combined efforts of two companies: La Calhène, a global capital equipment supplier headquartered in France that specializes in preventing product contamination from the ambient environment, and Newform, a Belgium-based, fully integrated manufacturer of ultraclean flexible packaging under Class 100 cleanroom conditions. Although the stainless steel cylinder is still offered with the DPTE system, the Ultraclean steam-sterilizable CleanConnect DPTEBetabag provides a number of advantages over the cylinder. The stainless steel cylinder is heavier and needs a hydrophobic filter to ensure that vacuum is formed and steam goes through, said Didier Meyer, marketing manager/ Pharmaceuticals for La Calhène. With the bag of polyethylene and Tyvek, we don t have these problems. The CleanConnect DPTEBetabag is significantly lighter in weight than stainless steel cylinders. And, because one side of the bag is made of Tyvek, vacuum can be formed and steam can enter and escape for uniform sterilization, making a hydrophobic filter unnecessary. Tyvek and a leak-tight head attached to the bag protect against bacteria after autoclaving. Filling and unloading sleeves on the bag prevent human contamination. The surface of the bag is clean and free of particulate debris, Meyer continued. Plus, it s easy to validate the integrity of each connection with a pressure increase system. Because all of the parts of CleanConnect DPTEBetabag are disposable, the bag can be discarded after a single use, eliminating the need for cleaning a reusable cylinder. And, the bag saves on valuable space. Newform worked in conjunction with La Calhène throughout the process of developing the bag and connecting system. The company makes the bag in any shape, design or size up to 7 x 3 according to each customer s specifications. Typically, double bags are requested. Tyvek is an integral part of both. We re a big user of Tyvek, said Stephane Huynen, Newform s managing director. Tyvek has excellent porosity and strength, and it s a very effective microbiologic filter. These qualities, combined with our ability to clean and process Tyvek under Class 100 cleanroom conditions, are all essential to the design of the Ultraclean steam-sterilizable CleanConnect DPTEBetabag. We sterilize up to 20,000 stoppers of 32 mm in diameter in our autoclave at one time, said Martin Kern, head of Aseptic Operations for Octapharma. The [CleanConnect DPTE ] outer bag provides an aseptic barrier, so there s no need for laminar flow storage of the sterilized bags. The easy-tear inner bag has eliminated the need for cutting with a scalpel or scissors. The system eliminates what used to be the last possibility for contamination. Octapharma has been using the DPTE system and CleanConnect DPTEBetabag at its production facility in Strasbourg, France, since August The company has been so pleased with the results that it began qualification of the system at its Vienna site in August. DPTE and DPTEBetabag are registered trademarks of La Calhène. CleanConnect is a registered trademark of Newform. 4

6 People on the Move Lori Gettelfinger A member of the DuPont Medical Packaging Team for nearly nine years, Lori Gettelfinger has been named New Market Development Leader for North America for the DuPont Nonwovens business. While she was a member of the DuPont Medical Packaging Team, Lori served as a marketing specialist and as an account manager. In these positions, she played a key role in determining marketing strategy and provided strategic direction for a variety of marketing activities, in addition to managing several health care manufacturing accounts. From 1994 to 1996, Lori also served as a founding co-chair of the Healthcare Resource Conservation Coalition, a nonprofit industry coalition established to minimize the impact of medical waste on the environment. Drawing on the breadth of her marketing/health care experience, Lori will be focusing her energies on developing new market opportunities for DuPont Nonwovens. In her new role as the New Market Development Leader, she also will be working with a global team to establish new businesses. We thank Lori for her many contributions to the DuPont Medical Packaging Team, and we wish her well in her new assignment. Mailing List Updates We are currently in the process of updating our distribution list for Tyvek Rx and would like your help. If you are receiving duplicate copies, have any corrections to your address information or would like to add a colleague to our mailing list, please send us an at medpkg@usa.dupont.com. Be sure to include name, company, job function, complete mailing address, phone and fax numbers. If you prefer, you can send this information to us via fax at Thanks for your help! H Copyright 2002 E.I. du Pont de Nemours and Company. Tyvek is a registered trademark of E.I. du Pont de Nemours and Company for its brand of protective material. All rights reserved. Tyvek Rx 71 Southgate Boulevard New Castle, DE PRESORTED STANDARD U.S. POSTAGE PAID Wilmington, DE Permit No. 460 RETURN SERVICE REQUESTED