Tyvek® IsoClean® Doffing procedure for an ISO 5 aseptic cleanroom
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Cleanroom Garment Validation & Compliance
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Advantages of DuPont Cleanroom Clothing
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Product Solutions & Industries
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Tyvek ® Recycling Program
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Resources
How To Validate Protective Cleanroom Garments?
The revision of the EU GMP Annex 1 for the manufacturing of sterile products aims to provide valuable information regarding this revision and its latest requirements.
Manufacturers of sterile products need to provide a proactive means of identifying, scientifically evaluating and controlling potential risks to quality and to ensure that microbial and particulate contamination is prevented in the final products. They must also implement a Contamination Control Strategy (CCS) across the facilities to define all critical control points and assess the effectiveness of all the controls (design, procedural, technical, and organisational) and monitoring measures employed to manage risks to medicinal product quality and safety.
Advantages of DuPont Cleanroom Clothing
The DuPont cleanroom clothing portfolio offers a comprehensive selection of single-use cleanroom garments and accessories designed for use in pharmaceutical, CDMOS, biotech, medical device, laboratory and electronic settings that require high standards for particle and microbiological contamination control.
They are available in many styles for different cleanroom and controlled environment applications and are packaged and certified to meet local market requirements. With the DuPont Controlled Environments offering, you get the advantage of reliable performance in contamination control, quality, traceability and cost efficiency.
Contamination control
- Inherently low linting
- Keeps microbiological and particle contamination inside the garment
Repels aqueous liquids and liquid aerosols
Sterilization
- Tyvek® IsoClean® sterile garments have a sterility assurance level (SAL) of 10-6, validated through bio burden and dose verification testing
Quality Assurance
- Lot Traceability & Documentation readily available upon request.
- The DuPont Controlled Environments quality management system complies with ISO 9001:2015 standards.
Packaging and Folding
- Available in many processing options, including clean-processed and sterile. Aseptic folding.
Quality control
- DuPont controls the entire manufacturing value chain, facilitating easier qualification and quality audits with lot-based certificates.
Budget Predictability
- Single-use garments reduce uncertainties related to garment repair, damage, and loss, allowing for better expenditure predictions.
Recycling
- Tyvek® IsoClean® garments may be eligible for recycling through the Tyvek® Protective Apparel Recycling Program.
Trusted Protection
- For over 20 years, Tyvek® IsoClean® garments have been an excellent choice for a variety of processes due to their excellent barrier to particles, microorganisms and non-hazardous liquids.
Product Solutions
<span class="fontsize22">Tyvek® IsoClean®<br></span> <span style="font-style: italic" class="fontsize16">For cleanroom contamination control in GMP A/B and ISO 4/5</span>
Provides an inherent barrier to particles, microorganisms, and non-hazardous light liquid splash.
Tyvek® IsoClean®, Clean-Processed and Sterile Options for GMP A&B and ISO 4/5 Controlled Environment ->
Tyvek® IsoClean® Sterile options ->
Tyvek® IsoClean® for GMP C&D and ISO 6/9 Controlled Environments ->
Tyvek® IsoClean® Non-Sterile Options ->
Tyvek® <br> <span style="font-style: italic" class="fontsize16"> For cleanroom contamination control in GMP C/D and ISO 6/9 </span>
An ideal balance of protection, durability, and comfort.
Explore Tyvek® 500 Xpert
Explore Tyvek® 500 Labo
Explore Tyvek® 600 Plus
Tychem® <br><span style="font-style: italic" class="fontsize16"> For cleanroom contamination control in GMP C/D and ISO 6/9 </span>
Protection from concentrated inorganic chemicals up to organic and highly concentrated chemicals as well as biological hazards.
https://www.dupont.co.uk/personal-protection/protective-apparel-contact-us.html
Industries
*Contract Development and Manufacturing Organizations
Tyvek® Recycling Program
DuPont™ Tyvek® is proud to expand our long standing Tyvek® Protective apparel recycling program to help our customers in Europe manage used Tyvek® and IsoClean® protective apparel and reduce wastage.
Resources
Solutions Guide for Controlled Environments
One of the areas in which safety and health are of paramount importance is in cleanrooms and controlled environments. The DuPont cleanroom clothing portfolio offers a comprehensive selection of single-use cleanroom garments and accessories designed for use in pharmaceutical, medical device, biotech and electronic settings that require high standards for particle and microbiological contamination control.
EU GMP Annex 1 Implications for Cleanroom Garments
The EU GMP Annex 1 was published on the 25th of August, 2022.
It requires that manufacturers of sterile products will apply the principles of Quality Risk Management (QRM) to the design and control of facilities, equipment (such as cleanroom garments), systems and procedures used for the manufacture of all sterile products.
Tyvek® protective apparel recycling program
The Tyvek® protective apparel recycling program offers the chance to divert garments away from landfills and give them a second life in products like containers, lumber pallets and park benches.
DuPont Webinar Academy
Each session will host our training managers and from time to time guest speakers, experts in the discussed fields. It will be an informative and interactive experience, which will allow you to not only gain valuable knowledge and training, but also receive a certificate of completion from DuPont Personal Protection.
Contamination & bioburden protection
As single-use protective clothing, DuPont™ Tyvek® IsoClean®, DuPont™ Tyvek® and DuPont™ Tychem® provide a range of products that deliver superior contamination and bioburden protection for products and processes in cleanroom environments.
Pharmaceutical and laboratory protection
With a wide range of industry-leading personal protective equipment (PPE) solutions and a global network of PPE specialists, technical experts and manufacturing, DuPont is uniquely suited to provide the protection and comfort every worker deserves to help them face a range of workplace hazards with confidence, as well as contamination control for every product in diverse pharmaceutical environments.
Cytostatics contamination protection
Cytostatics are used as drugs in cancer therapy (chemotherapy) to inhibit the multiplication of tumour cells and are also used increasingly to treat other diseases. However, their toxicity affects not only tumour cells but also healthy cells.
Chemical protection
Industrial workers work with and around hazardous particles and chemical vapors and liquids every day. DuPont scientists evaluated the hazards and came up with solutions for personal protective clothing that offers durability, comfort and uncompromised protection that doesn’t wear away, as is the case with many other protective materials.
Videos
Case Studies & Articles
DuPont E-Guide Explains How to Protect Workers From the Risk of Highly Potent Pharmaceutical Ingredients
The e-guide – entitled The HSE Manager’s Guide to Cleanroom Garments for HPAPI Manufacturing – offers an overview of HPAPI risks, including potential harm to cleanroom operatives from exposure to hazardous substances and contamination of pharmaceutical products.
Giving Disposable Cleanroom PPE a Second Life to Reduce Plastic Waste
DuPont Has Helped Leading Pharmaceutical Manufacturer, Boehringer Ingelheim Dortmund, Recycle 99 Percent of Its DuPont™ Tyvek® Garments.
Icrom chooses the high level of chemical protection for their employees
The Italian pharmaceutical industry is internationally renowned for its high technology and innovation. To maintain its high product quality, companies operating in this sector undergo numerous controls and work under stringent procedures. One of the fundamental aspects of the production chain is chemical protection for operators that manipulate hazardous substances and, at the same time, protection of the operational processes.
Tyvek® IsoClean® garments partnered with the powered air ViVi®-CR helmet
Clean-processed and sterile, single-use Tyvek® IsoClean® garments made from patented, breathable and low linting Tyvek® fabric, partnered with the powered air ViVi-CR helmet and sterile hood system, provide a cool working environment with sterility assurance.
Single-use Tyvek® IsoClean® vs. Polyester reusable textile
Once again, DuPont scientists tested the barrier performance of a commercial polyester, reusable textile garment, typically used in European cleanrooms and Clean & Sterile Tyvek® IsoClean® garment model IC 183 B DS. The tests were performed on new garments and results do not include garment wear and multiplewashing and irradiation cycles.
