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Clean and Sterile PPE for Life Sciences

Operator in full Ansell cleanroom coverall, hood, and gloves working with precision in a sterile lab, highlighting product integrity and safety.

In Life Sciences, product protection is critical. Whether you're developing life-saving biologics or assembling sterile medical devices, or conducting essential laboratory research every step must meet strict contamination control standards.

Ansell’s Life Sciences PPE solutions are specifically developed to minimize contamination risk by containing operator-borne particulates and microbes, while also providing effective protection against chemical hazards, ensuring both product and process integrity and personnel safety in controlled environments.

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LIFE SCIENCES GLOVES & BODY PROTECTION AT A GLANCE

From pharmaceutical manufacturing, biopharma, and medical device production to laboratories, research facilities, and compounding pharmacies, Ansell delivers product protection solutions and PPE solutions that meet the highest standards for aseptic and cleanroom environments.

Our comprehensive portfolio includes sterile and non-sterile cleanroom gloves, coveralls, goggles, face masks, accessories, and RABS/isolator gloves – helps safeguard product integrity, supports your contamination control strategy, ensures regulatory compliance, and protects your operators during critical processes.

Image of Ansell PPE in action representing Ansell's safety solutions in regards to product integrity and safety

Aseptic Cleanroom Environments

Protecting products in pharmaceutical manufacturing, medical device manufacturing and biopharma is vital to ensure patient safety, maintain product efficacy, and comply with stringent regulatory standards.

Contamination from microorganisms, particles, or chemicals can compromise sterile products, leading to serious health risks and costly recalls. Since people are the primary source of contamination in cleanroom environments, wearing the right personal protective equipment (PPE) is essential. Properly selected and worn PPE helps prevent the shedding of particles and microorganisms, ensuring a controlled environment that supports the production of safe, high-quality pharmaceuticals.

EXPLORE OUR LIFE SCIENCES PPE RANGE

KEY SOLUTIONS

Versatile Sterile Gloves: Including extended lengths (300mm/12"" to 400mm/16"") for easy dab test disinfecting and enhanced coverage, available in various materials for optimal cleanliness and chemical protection.

Coloured sterile gloves for immediate visual alerts via double donning systems, enhancing safety and contamination control.

Type 5 & 6 certified coveralls, hoods, overboots, sterile single-use or autoclavable goggles, and multiple facemask styles for superior barrier performance and comprehensive protection.

Access sterility, conformance, and chemical permeation certificates for full regulatory compliance and product validation.

Double or triple bagged PE packaging for minimal contamination risk during transfer and cleanroom-compatible handling.

FAQ

A cleanroom controls airborne particulate contamination to specified levels, reducing general contamination. A sterile cleanroom (or aseptic cleanroom) has even stricter controls, specifically designed to prevent microbial contamination. This involves rigorous sterilization processes for everything entering the room, and requires sterile PPE, making it suitable for manufacturing sterile products like injectables or medical devices.
In sterile cleanroom environments, personnel require sterile PPE that prevents both particulate and microbial contamination. This typically includes sterile cleanroom gloves (often extended length for double donning), sterile coveralls, hoods, overboots, sterile goggles, and facemasks. All packaging for this PPE must also be cleanroom-compatible and sterile.
To ensure your PPE meets EU GMP Annex 1 for sterile manufacturing, you must select PPE specifically certified for sterile environments. This involves verifying sterility assurance levels (SAL), ensuring the PPE is low-particulate shedding, and having documentation like Certificates of Conformance, Irradiation, and chemical permeation. Regular training on proper donning/doffing procedures and adherence to strict contamination control protocols are also crucial. For more in-depth insights into EU GMP Annex 1 requirements and how Ansell's protective solutions can help you achieve and maintain compliance, you can refer to our blog post: EU GMP Annex 1: Are You Dressed for the Part?
Yes, nitrile gloves generally offer good chemical resistance against a wide range of chemicals, making them a popular choice in many laboratory and industrial settings. However, their specific resistance varies depending on the chemical, concentration, temperature, and glove thickness. Always refer to the manufacturer's chemical resistance guide (like the EN ISO 374 standard mentioned on the page) for specific chemical permeation and degradation data before use.
For allergy-sensitive personnel, nitrile gloves are generally the best option as they are latex-free, which eliminates the risk of Type I (latex protein) allergies. Many nitrile gloves, like the Ansell Nitrilite 93-401 from our range, are also accelerator-free, further reducing the risk of Type IV (chemical accelerator) allergies, making them suitable for individuals with sensitive skin or allergies to common glove chemicals.
Image of cleanroom gloves made for life sciences industry