Choosing the Right Pharmaceutical Single-Use Garments…

Choosing the Right Pharmaceutical Single-Use Garments…

Choosing the Right Pharmaceutical Single-Use Garments

In the Pharmaceutical Environment, There are Two Main Risks: Safety and Contamination.

Pharmaceutical employees may work with hazardous drugs and, while as many precautions as possible should be taken to prevent it, direct exposure is always possible. That’s why there are health and safety regulations to protect workers from potential hazards, including periodic risk assessments according to OSHA’s 29 CFR 1910.132. Contamination of the cleanroom environment can also impact the quality of manufactured drugs. While cleanrooms are designed to restrict the number of airborne particulates, most contamination is caused by particles emitted from people working in the area. According to the Institute of Validation Technology: "While there are multiple sources for particle generation, personnel are the main contributors of particles in cleanrooms as well as the primary source of microorganisms. Hence, while a risk can arise from the influx of contaminated air into a cleanroom this is less likely to occur within a correctly functioning cleanroom with effective air filtration; the greater risk is with what happens to particles shed from people working within the cleanroom when such particles enter the air stream.”

One of the best ways to reduce the spread of contamination is by wearing the correct PPE garments that match the ISO classification of your cleanroom.

Pharmaceutical manufacturers stand to lose millions each year from cross-contamination of products, and pharmaceutical impurities can tamper with patient safety and consumer confidence. To limit contamination, cleanrooms have ISO environmental and administrative standards and requirements, including the mandated use of personal protective equipment (PPE). One of the best ways to reduce the spread of contamination, for example, is by wearing the correct PPE garments that match the ISO classification of your cleanroom. Thanks to their reduced cross-contamination risk and cost-effectiveness, single- use garments are ideal for the pharmaceutical industry.

Quest Protective Apparel

Choosing the Right Pharmaceutical Single-Use Garments

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5 Benefits of Single-Use Garments

Below, we’ll share the top benefits of single-use garments and what to look for when choosing single-use garments for your cleanroom.

1 Reduced Cross-Contamination Risk The fabric used to make many single-use garments has antibacterial properties which make them ideal for a cleanroom. The fact that they are disposable is also ideal, especially compared to traditional clothing that is washed over and over again, sits in a cabinet for potentially weeks before being worn, and is handled by several people during the laundering process. (See our article Single-Use vs Reusable Garments for more information on this topic.) In fact, the entire laundering process puts the fabric under additional stress, creating pockets for bacteria to reside. Many single-use garments are wrapped in plastic, staying clean and untouched until use. A standard practice of applying new garments before entering the cleanroom and disposing of them when leaving will help reduce possible contamination. 2 Cost-Effective Financially, it may seem counterintuitive to use a garment once and then throw it away, but single-use garments save companies money in the long run. This is because the non-woven synthetic fibers that single-use garments are made from are inexpensive, making single-use protective clothing a simple and cheap option that can be purchased in bulk. Plus, you save money that would otherwise be spent on cleaning and sanitizing garments.

3 Less Waste Sustainability is becoming a priority for many organizations, and disposable safety apparel can help manufacturers reduce waste and contamination risk. Many single-use garments are designed to avoid touching the floor while gowning, keeping them clean and uncontaminated so they don’t have to be thrown away before they can be used. For example, single-use coveralls often include internal snaps to hold up the arms and legs as the worker puts them on. Airtight vacuum seals also reduce waste due to contamination during transport to sterile locations. 4 More Efficient On average, single-use garments take up about 50% less space than reusable protective clothing. Employees wearing disposable clothing are also less likely to need time away from job duties to clean or change contaminated garments. Automatic dispensers are also quicker and more efficient than manual gowning, allowing workers to quickly don safety garments. 5 Compliant For certain high-class cleanrooms, disposable garments are required because they are the best way to avoid contamination. Choosing single-use garments ensures your facility is doing the best job possible of avoiding contamination risks.

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Choosing the Right Pharmaceutical Single-Use Garments

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What to Look For When Choosing Single-Use Garments

A standard practice of applying new garments before entering the cleanroom and disposing of them when leaving will help reduce possible contamination.

There are many options for single-use garments available. Keep in mind that the comfort and fit of PPE are critical to keep workers focused on accomplishing tasks, leading to better productivity and quality. Here are a few key characteristics you should consider when choosing the best single- use protective clothing for your needs: • Easy to put on and take off • Durable yet breathable fabric that does not shed fibers (low-linting, no raw edges) • Material that meets industry standards to protect against hazardous chemicals and particulates • Choose the appropriate material - you’ll need different garments depending on whether employees are working with liquids or particulates • Seams appropriate for the needs of your environment • Tunneled elastic at ankles and wrists for comfort and secure closure • Individually packaged and pre-sterilized when needed • Make sure your PPE matches the ISO requirements for your environment

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Choosing the Right Pharmaceutical Single-Use Garments

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Quest Protective Apparel’s Single-Use Garments

Quest Safety developed a range of single-use garments to fulfill the needs of pharmaceutical customers who requested protective apparel with specific features and needed a consistent supply chain to satisfy regulatory requirements. The first Quest Comfortwear suit, created specifically to solve a problem for a pharmaceutical customer, has grown into an entire line of suits, coveralls, lab coats, and shoe/boot covers. Each product was designed with input from Industrial Hygienists, safety managers, and end users to solve specific, real-world problems, and were manufactured in FDA-registered, ISO-certified clean facilities to pass cleanroom standards. As a result, these single-use garments increase safety, create a stronger supply chain, and often dramatically lower costs. The Real World Design of Quest Protective Apparel puts more material in high-stress areas such as the shoulders, crotch, and seat, reducing blowout and increasing savings. The sizing takes into account the sizes of workers who may be wearing layers under the suits, providing room to move comfortably and increase productivity.

On average, single-use garments take up about 50% less space than reusable protective clothing.

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Quest Shoe and Boot Covers Quest Safety’s Traction Shoe Cover and Boot Covers feature a proprietary state-of-the-art traction sole that provides unparalleled skid resistance on both wet and dry surfaces. The shoe and boot cover material is low-linting and resistant to light splashes from non-hazardous chemicals. Our Traction Boot Cover with Heel Strap offers a unique heel strap to tighten the slack at the toes and heels, providing users a more secure, safe fit. Options include: QPA ® Traction Boot Cover • Anti-Slip - High Coefficient of Friction • Clean Manufactured • Low Linting - Helmke Drum Test Results: CAT II • Proprietary sole incorporated into a boot cover to provide extended coverage. • Learn more: QPA ® Traction Boot Cover QPA ® Traction Boot Cover with Heel Strap • Anti-Slip - High Coefficient of Friction • Clean Manufactured • Low Linting - Helmke Drum Test Results: CAT II • Heel straps added to our Traction Boot Cover to offer a tighter fit for safer use. • Learn more: QPA ® Traction Boot Cover with Heel Straps QPA ® Traction Shoe Cover • Anti-Slip - High Coefficient of Friction • Clean Manufactured • Low Linting - Helmke Drum Test Results: CAT I • Proprietary sole incorporated to increase traction, help eliminate slips, trips, and falls. • Learn more: QPA ® Traction Shoe Cover QPA ® Q-Stik ® Shoe Cover • Anti-slip - High Coefficient of Friction. Helmke Drum Test Results: CAT I • Water Resistant, Clean Manufactured • Low Linting - Helmke Drum Test Results: CAT I

QPA ® Traction Boot Cover

QPA ® Traction Boot Cover with Heel Strap

QPA ® Traction Shoe Cover

• Cost savings and secure supply chain • Learn more: QPA ® Q-Stik Shoe Cover

QPA ® Q-Stik ® Shoe Cover

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QPA Comfortwear® Suits Quest Comfortwear suits are designed to be used in light liquid splash and dry environments where the main goal is staying clean. They are clean manufactured, low-linting, meet NFPA 99 antistatic requirements and are ISO Class 5 compatible. The first Quest Comfortwear suit was created in 2002 specifically to solve a supply chain problem for a pharmaceutical customer. QPA Barrierwear ® Suits Quest Barrierwear suits are designed to be used in dry and liquid spray and splash environments where the main goal is to stay clean, comfortable, and protect critical products. These suits are very popular in pharmaceutical environments due to their clean manufacturing, low linting, and breathability. QPA Quantumwear ® Suits Those wearing Quest’s Quantumwear suits are working with some of the most hazardous, dangerous contaminants in the world. A personal contamination event can cost a company anywhere from $5,000 to $40,000 per incident. These suits are designed to withhold dry and liquid particles. The patented design of the hood and neck area dramatically reduces the risk of contamination during the donning, doffing, and decontamination processes. Superior design features an adjustable neck closure system. The specially designed doffing tabs and sequenced, peel-away procedure eliminate contamination risk—an industry best practice. Click here for an introductory video on Quantumwear suits. These cost-effective suits feature larger sizing, increased mobility, superior protection, comfort, and durability. QPA Quantumwear ® C Suits Quest took the Quantumwear suits, increased the suit’s ability to protect workers against chemicals as well as its comfort and wearability, and created the Quantumwear C line of suits. These suits are compliant with ASTM F1670 Blood Borne Pathogen, ASTM F1671 Viral Penetration, NFPA 99 Antistatic, and ASTM F739 & F903 Challenge Chemical Tests.

QPA Comfortwear ® Suits

QPA Barrierwear ® Suits

QPA Quantumwear ® Suits

Contact Quest Safety for Quality Single-Use Garments Single-use garments are a cost-effective way for pharmaceutical manufacturers to keep employees and work environments safe, sanitary, compliant, and efficient. Quest Safety Products offers state-of-the-art single-use garments designed specifically for pharmaceutical environments. Contact your territory manager today to help you find the best single-use garments for your needs.

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www.QuestSafety.com [email protected] 1.800.878.4972