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Why Life Sciences Leaders Trust Ansell Cleanroom Product Protection Solutions

In the High-Stakes World of Life Sciences, Product Protection is Paramount

Pharmaceutical manufacturing, biopharma innovation, and advanced medical device microelectronics operate at the cutting edge of human progress, but they also face some of the world’s highest contamination, compliance, and operational risks.

In these environments, personal protective equipment (PPE) is not just about operator safety, it’s the frontline defense for product protection. A single breach can trigger cGMP deviations, product recalls, regulatory action, and loss of public trust.

That’s why life sciences industry leaders worldwide rely on Ansell cleanroom PPE solutions, for integrated head-to-toe cleanroom product protection designed to maintain barrier integrity, support Annex 1 compliance, and protect both products and people.


The Risk and Regulatory Landscape Has Never Been Tougher

Cleanroom and controlled environments are under unprecedented pressure.

  • Annex 1 of EU GMP now places greater emphasis on Contamination Control Strategies (CCS), aseptic processing, and barrier systems, raising the stakes for gowning practices, glove integrity, and sterility assurance.
  • The global cleanroom equipment market is growing at a CAGR of 6.3% (2023–2030)1, driven by compounding pharmacies, sterile manufacturing, and semiconductor production.
  • FDA and EMA inspections are more frequent, with sterility failures and cGMP deviations among the top causes of recalls2.
In 2023 alone:
  • 567.4 million defective pharma units were recalled in the U.S.3, with sterility as the top cause by number of events.
  • Leakage, contamination, and quality concerns accounted for millions more units lost, directly impacting product integrity.
For Annex 1 compliance insights, see:

Why Ansell is the Partner of Choice for Cleanroom Product Protection

Our promise, “Leading the world to a safer future” is backed by five strategic pillars that work together to deliver unmatched product and process protection.


1. Deep Knowledge – Anticipating and Preventing Risk


With 130+ years in safety innovation and 700+ regulatory and quality experts, we understand the hazards, workflows, and compliance demands of every life sciences application.

Owning 6 in-house ISO Class 4, 5, & 7 cleanrooms and 3 gamma irradiation facilities gives us full process control from manufacturing, post processing and sterilization, reducing contamination risk and ensuring consistent quality.

Our exclusive Ansell Cytostatic Permeation Program (ACPP) tests gloves under real-use/dynamic conditions, giving you accurate chemical permeation data to protect products in critical processes.


2. Unrivalled Portfolio – Head-to-Toe Annex 1-Ready Solutions

Staying Annex 1 compliant has never been easier. From sterile cleanroom gloves and RABS/isolator sleeves to aseptically packaged and presented garments and cleanroom goggles. Ansell’s broad portfolio is designed to meet the specific needs of life sciences applications. Every product is rigorously tested to the most stringent global standards, ensuring both product protection and operator safety.

Application-specific examples:

With BioClean™, Kimtech™, TouchNTuff™, and DermaShield™, Ansell delivers one of the industry’s most comprehensive head-to-toe cleanroom PPE portfolios, giving life sciences professionals the confidence to meet Annex 1 requirements and protect their products without compromise.

3. Resilient Global Network – Supply Security for Product Protection

With 14 manufacturing facilities, 24 distribution centers, and a diversified global supply chain. By diversifying manufacturing, we are able to achieve greater supply chain flexibility and mitigate supply disruptions, enabling us to maximize on-time and in-full product delivery.

Our multi-sourcing strategy ensures uninterrupted PPE availability, protecting your ability to maintain product quality without supply chain disruptions.


4. Effective Partnerships – Beyond Products to Safety Outcomes

Through AnsellGUARDIAN™ assessments, we provide tailored PPE strategies that optimize product protection, reduce SKUs, and cut costs.

Since 2010, we’ve delivered:

$170M

in PPE savings

65%

injury reduction

25%

portfolio simplification

5. Sustainable Future – Ansell Earth and Product Stewardship

Through the Ansell Earth program, we integrate sustainability into every product lifecycle stage:

  • Material – Low-impact, high-performance materials.
  • Manufacturing – Energy and waste reduction across all sites.
  • Packaging – 100% recycled cartons, 30% recycled HDPE liners.
  • Use – Durable PPE that reduces replacement waste.
  • End of Use – Responsible disposal and recycling initiatives, including Ansell’s RightCycleTM Program, which helps customers collect and recycle used PPE such as cleanroom gloves, transforming them into new plastic products and reducing landfill waste. Learn more.

Our Cleanroom Packaging Innovations

As part of the Ansell Earth program, we are rethinking every element of cleanroom packaging to reduce environmental impact while maintaining the highest standards of product protection and sterility.

  • SMART Pack – Our innovative design solution reduces CO₂eq by 27 tons and eliminating nearly 1 million plastic bags annually.
  • Garment Kits – Pre-assembled sterile garment kits that reduce the need for multiple single-use bags and simplify aseptic gowning, lowering both packaging waste and contamination risk.
  • Improved Isolator Glove Packaging – Streamlined triple-bagged formats with optimized outer materials for reduced plastic use and faster cleanroom transfer, without compromising sterility assurance.

Together, these innovations are helping our life sciences partners meet sustainability targets, improve gowning efficiency, and protect critical products from contamination.


Worker Experience Innovation (WEI) – Comfort Without Compromise

Through our WEI technologies, we ensure PPE is comfortable and easy to use, reducing donning errors and improving compliance.

Our technologies include:

  • DERMASHIELD™ – Proprietary coating that enables fast, effortless donning on wet or dry hands, reducing the risk of touching non-sterile surfaces during glove changes.
  • PI-KARE™ – A skin-friendly, accelerator-free formulation that eliminates common chemical allergens, lowering the risk of dermatitis that can cause operators to miss shifts in sterile production areas.
  • ERGOFORM™ – Ergonomic design technology that minimizes muscle strain and hand fatigue during long production runs, improving precision and reducing the likelihood of handling errors.
  • SENSOPRENE™ – A breakthrough neoprene formulation that is 30% thinner without compromising strength or barrier integrity, offering exceptional tactile sensitivity for delicate aseptic tasks.
  • TNT™ – Advanced chemical splash resistance to protect operators — and the products they handle — from accidental contamination when working with potent active ingredients or cleaning agents.

By integrating these innovations, Ansell helps life sciences teams maintain compliance with Annex 1 gowning requirements, improve operator endurance, and safeguard the product’s sterile barrier from start to finish.


Recognized for Sustainability Excellence

These awards reflect more than corporate recognition, they validate the trust our life sciences partners place in us to protect products, people, and the planet without compromise.


Annex 1 Compliance and Complete PPE Integration

Annex 1 requires a holistic contamination control strategy, where gowning, gloves, goggles, and other PPE work in synergy to maintain product protection.

Ansell ensures:

Barrier integrity at every stage

Ease of aseptic donning to minimize human error

Secure, consistent supply for business continuity

For more, see:


The Strategic Advantage of Choosing Ansell

When you choose Ansell, you’re securing:

  • Proven contamination and product protection
  • Solutions for every cleanroom process
  • Resilient supply chain security
  • Expert consultancy for compliance and efficiency
  • Sustainability credentials that enhance your ESG profile

In the high-stakes life sciences sector, the wrong PPE choice can cost far more than the right one. Ansell’s integrated approach keeps you two steps ahead, protecting your people, your products, and your future.

When people feel safe, there’s no limit to what they can achieve. Contact our Cleanroom PPE Experts to design your head-to-toe product protection strategy today.


References:
1. https://www.grandviewresearch.com/industry-analysis/cleanroom-equipment-market-report
2. https://www.ammex.com/market-update-page-january-2024/
3. Sedgwick Brand Protection – U.S. State of the Nation 2023 Index Report