DuPont Tyvek delivers trusted protection for pharmaceutical products

Transcription

1 DuPont Tyvek delivers trusted protection for pharmaceutical products

2 Protect your products and processes with DuPont Tyvek For the past 40 years, DuPont Tyvek has been helping to protect the health of literally millions of patients worldwide. Recognized as a standard of excellence in healthcare packaging, Tyvek is used in virtually every form of sterile medical packaging and a wide variety of pharmaceutical applications both sterile and non-sterile. Tyvek styles for medical and pharmaceutical packaging applications are manufactured to rigorous quality standards to meet the unique requirements of these highly regulated industries. They meet all the acceptable performance criteria for biocompatibility even after sterilization when tested according to ISO and United States Pharmacopeia (USP). In addition, they meet the extractable or composition requirements of various food contact and pharmacopeia regulations such as 21 CFR , Commission Regulation (EU) Nº 10/2011 and European Pharmacopoeia, Section

3 From stopper bags to pre-filled syringes, DuPont Tyvek has you covered With its unique balance of properties, Tyvek delivers trusted protection for a wide range of pharmaceutical packaging applications, helping pharmaceutical companies around the world to: Enable sterilization and protection of parts for sterile pharmaceutical processing; Ensure sterility maintenance of components such as closures, stoppers and pre-fillable syringes prior to entering your sterile manufacturing area; Protect injectable drug and vaccine products; Provide a high degree of protection for drug and device combination products such as drug-coated stents; and Enhance the presentation and ease-of-use of sterile and non-sterile products in peel pouches, header bags and tray and lid configurations. DuPont Tyvek the material of choice for pharmaceutical applications Made of high-density polyethylene (HDPE), Tyvek has inherent advantages over other materials. Tyvek is vapor permeable, yet water- and chemical-resistant. It offers an optimum balance of microbial penetration resistance, tear strength, puncture resistance and low-linting features. Outstanding resistance to microbial penetration Tyvek also offers compatibility with a broad range of sterilization methods and features a smooth, opaque white surface that can be printed using standard commercial printing equipment. inherent barrier to microorganisms down to one micron The unique structure of DuPont Tyvek tough, continuous fibers creates a tortuous path with substantial lateral movement, resulting in superior microbial barrier properties. Even under the most rigorous conditions, Tyvek is highly resistant to penetration by bacterial spores and other contaminating microorganisms. 4 5

4 Number of particles Untorn 35,000 30,000 25,000 20,000 15,000 10,000 5,000 1, Number of particles After tearing in half 35,000 30,000 25,000 20,000 15,000 10,000 5,000 1, Low risk of particle contamination Unlike paper, which can release a significant number of particulates when a package is opened, Tyvek is known for its low linting and clean peel features. Low linting reduces the risk of contamination, helping you meet increasingly stringent industry and regulatory requirements. Particulate generation tests comparing Tyvek to medical-grade papers provide conclusive evidence that Tyvek generates far fewer airborne particulates that could contaminate either your product or the sterile field. (See Figure 1.) Very low bioburden The process of manufacturing Tyvek allows only short periods of time when the sheet is subject to airborne particulates and microbes; therefore, the bioburden on the surface of the Tyvek is very low. And, unlike cellulose-based packaging, Tyvek does not support the growth of microbes. Significantly reduced risk of package failure The tough, continuous fibers of Tyvek help protect package integrity even during rough handling. Tyvek does not puncture easily and tears do not readily propagate if a package is nicked. What s more, because it is breathable, Tyvek minimizes the formation of condensation, so it performs well in multiple environments warm or cold storage and high altitude shipping µ 0.5 µ 1.0 µ 2.0 µ 5.0 µ Particle size (microns) 10.0 µ 0.3 µ 0.5 µ 1.0 µ 2.0 µ 5.0 µ Particle size (microns) DuPont DuPont 44# medical- 60# medical- 44# medical- Tyvek 1073B Tyvek 1059B grade paper grade paper grade paper Figure 1. Particle generation properties of DuPont Tyvek styles and medical-grade papers (as tested by an internal DuPont protocol). For the particulate generation testing, samples (medical-grade papers, as well as Tyvek 1073B and Tyvek 1059B) were each tumbled in a tumbling drum to release particles from the tested materials. The drum was housed in a HEPA filter lab bench. The lab bench air was filtered with two pre-filters and one HEPA filter. Air was supplied by a blower with a pressure drop across the filters of 0.5 in. (1.3 cm) of water. Sampling of the number and size of the generated particles was done with a cleanroom monitor coupled to a paper tape printer. All of the equipment was housed in a temperature-controlled, HEPA-filtered-air cleanroom that had full air exchange approximately every minute µ Compatibility with a broad range of sterilization methods Unlike kraft and medical-grade papers and films, Tyvek is compatible with all of the most commonly used sterilization methods, including: ethylene oxide (EO), steam (under controlled conditions), gamma, electron-beam and low-temperature oxidation. And, because Tyvek is specially engineered to enable sterilant gases and steam to penetrate and escape quickly, it will retain its superior protective properties no matter which sterilization method you choose. Helps you meet your environmental goals Tyvek is produced under verified environmental management policy according to ISO It can be recycled at local recycling facilities that accept HDPE waste according to local legislation. The items sent for recycling must not have been in contact with any hazardous substance. 6 7

5 For more information about DuPont Tyvek for pharmaceutical packaging, call us today at TYVEK or visit us at This information is based upon technical data that DuPont believes to be reliable. It is subject to revision as additional knowledge and experience are gained. DuPont makes no guarantee of results and assumes no obligation or liability in connection with this information. It is intended for use by persons having technical skill for evaluation under their specific end-use conditions at their own discretion and risk. Since conditions of use are outside our control, we make no warranties, expressed or implied, including without limitations, no warranties of merchantability or fitness for a particular use and assume no liability in connection with any use of this information. This information is not intended as a license to operate under or a recommendation to infringe any patent or technical information of DuPont or others covering any material or its use. Copyright 2013 DuPont. All rights reserved. The DuPont Oval Logo, DuPont, The miracles of science, and Tyvek are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates. K (2/13)