Guiding pharmaceutical manufacturers in choosing cleanroom gloves: balancing performance, compliance and sustainability

Walid El Azab, Co-Founder and Senior Consultant, QP Pro Services & QPM Consulting

Introduction

In pharmaceutical manufacturing, cleanroom gloves are essential for controlling contamination, safeguarding product integrity and protecting operator health. Whether the environment is sterile, non-sterile or a laboratory, glove choice is a key decision that rests on several criteria: safety, functionality and performance for the intended use. Another major consideration is sustainability, with growing attention to Environmental, Social and Governance (ESG) factors.

This article sets out a structured framework to help pharmaceutical manufacturers make informed choices about cleanroom gloves. It stresses the importance of balancing performance, compliance and sustainability. By building in regulatory requirements and ESG priorities, it aims to align glove selection with a company’s sustainability goals while keeping operations compliant. Finally, a decision tree is presented as a practical tool to guide glove selection.

Essential criteria for choosing cleanroom gloves

Cleanroom gloves used in pharmaceutical applications must meet strict regulatory and quality standards to ensure safety, functionality and performance. In Europe, these gloves fall under Regulation (EU) 2016/425, which sorts personal protective equipment (PPE) into three categories (1):

• Category I: PPE for minimal risks.
• Category II: PPE for moderate risks.
• Category III: PPE designed to protect against serious or irreversible risks to health.

Given the potential exposure to chemical and biological hazards in pharmaceutical environments, cleanroom and laboratory gloves must be certified as Category III PPE to ensure adequate protection.

Glove manufacturers must meet the essential health and safety requirements, complete a conformity assessment and affix the CE marking to demonstrate compliance. Responsibility for product safety extends across the whole supply chain, including manufacturers, authorised representatives, importers and distributors.

Cleanroom gloves must comply with European and international standards for safety and performance in pharmaceutical environments. General requirements such as fit, comfort and ease of use are assessed under ISO 21420:2020. Durability is essential for prolonged use and lasting protective integrity. The tests include:

• Pinhole defects (micro-perforations): ASTM D5151-19
• Tensile strength and elongation (how far the material stretches before it breaks): ASTM D412-16
• Cleanliness: IEST-RP-CC005.4, ASTM D6124-06
• Chemical resistance and barrier efficacy: ISO 374 series (ISO 374-1:2024, ISO 374-2:2019, ISO 374-4:2019, EN 16523-1:2015+A1:2018)
• Microbial barrier efficacy: ASTM F1671/F1671M-22, ISO 374-5:2024

Additional standards or test methods may be needed, depending on the end user’s requirements. For example, gloves intended for aseptic areas must meet the ISO 11137 series for sterilisation, while gloves used in the manufacture of chemotherapy drugs must comply with USP <800> or be tested to ASTM D6978-05:2023 for resistance to cytotoxic drugs.

Criteria to consider when choosing gloves

The industry has moved from PVC (vinyl) and latex gloves to nitrile gloves because of their excellent hypoallergenic properties, chemical resistance, flexibility and cost advantage (2-5). Although highly elastic, latex gloves carry a risk of type I hypersensitivity (an immediate-type allergy to natural rubber latex proteins) and vary from batch to batch because of their natural origin (6-8). Vinyl gloves, for their part, are less durable and offer limited chemical resistance (2-5). Nitrile gloves combine durability, flexibility, safety and cost, which makes them the preferred choice (2-8).

Glove safety, functionality and performance depend on the manufacturing process, which determines quality, cleanliness and compliance with the applicable standards. Understanding these manufacturing stages is essential for an informed decision:

1. Mould preparation. The process starts by cleaning the hand-shaped moulds (known as formers), which are dipped in turn into acid, aqueous and alkaline solutions. This step removes residual impurities and ensures the purity of the finished gloves.

2. Dipping and vulcanisation. The cleaned formers are coated with a coagulant, then dipped into latex or nitrile formulations. Chemical accelerators, such as thiurams or dithiocarbamates, promote vulcanisation (the cross-linking of the polymer chains) by creating bonds between those chains. This improves elasticity, durability and tear resistance. However, these accelerators can provoke type IV hypersensitivity (a delayed-type allergic contact dermatitis), which is pushing the industry towards accelerator-free nitrile gloves (8).

3. Chlorination and surface treatment. After vulcanisation, gloves are chlorinated, which reduces surface tack and improves comfort and ease of donning. A second chlorination, often carried out offline, removes residual contaminants and optimises the cleanliness and smoothness of the outer surface.

4. Cleanroom processing. Rigorous washing cycles (for example with filtered deionised water) are applied, followed by drying with HEPA-filtered air. The gloves are packed in a controlled environment, and those intended for sterile applications are sterilised by gamma irradiation or ethylene oxide.

A. Glove safety factors

1. Process compatibility. Glove materials must withstand chemical degradation, frequent disinfection and mechanical stress to ensure extended use and reliability. Choosing the right glove material means matching the specific manufacturing requirements, notably chemical exposure, mechanical stress and contamination control.

• Process-specific needs: For example, gloves used in the manufacture of chemotherapy drugs must comply with ASTM D6978-05:2023 and USP <800> to ensure adequate chemical barrier properties. Gloves used in wet operations must resist permeation by chemical cleaning agents or solutions. Conversely, gloves for dry operations should prioritise electrostatic discharge properties to avoid the hazards of static electricity.
• Aseptic cleanrooms: Sterile gloves are mandatory to maintain contamination control in aseptic cleanrooms. Gloves are often worn continuously for up to 4 hours and need frequent disinfection, generally every 5 to 10 minutes, because of contact with critical surfaces and materials. This frequent disinfection, mainly with 70% isopropyl alcohol (IPA), is essential for effective microbial control (10). However, repeated exposure to IPA can degrade the integrity of glove materials over time, increasing the risk of pinholes (micro-perforations) and potentially compromising contamination control (11-13). To mitigate this risk, regular glove replacement programmes are essential to preserve glove integrity, maintain performance and ensure aseptic conditions in cleanroom environments (14).

2. Allergen mitigation. Latex-free gloves, and accelerator-free nitrile gloves in particular, effectively reduce the risk of type I and type IV hypersensitivity (6-9). Accelerator-free nitrile gloves help prevent allergic reactions, which is consistent with the EU REACH Regulation (EC 1907/2006) restricting hazardous substances.

3. Cleanliness for cleanrooms. Cleanroom gloves must respect the cleanliness of the cleanroom and its intended use:

• Low-particle and residue-free standards: Gloves must meet specific cleanliness requirements according to the process and the environment in which they are used. Cleanroom gloves must not generate particles or contaminants that could compromise the particulate cleanliness of the cleanroom, whose limits are described in ISO 14644-1:2015. The glove manufacturer must therefore provide evidence of particle counts or cleanliness properties, using the test method in IEST-RP-CC005.4 for cleanroom gloves or ASTM D6124-06 (2022) for laboratory gloves, so that residual powder levels stay below 2 mg and meet the industry benchmark for residue-free performance.
• Microbial barrier properties: Gloves used in operations involving contact with human organs, materials, other blood derivatives or other biological agents must demonstrate resistance to penetration.

B. Glove comfort

Operator comfort is a key factor influencing performance and adherence to standard operating procedures (SOPs) in cleanroom environments.

1. Ergonomic design. Gloves with a thin fingertip and palm design, combined with high flexibility (tensile strength), improve tactile sensitivity. This is a vital characteristic for aseptic or complex, precise operations that require delicate handling of materials (3,4).

2. Proper fit. Gloves must be the right size to maintain dexterity. The criteria to consider are:

• Texture: Textured fingertips and palms improve grip, giving better control of tools and materials.
• Surface tack: Smooth gloves make it easier to don a second glove (double gloving), while slightly tacky surfaces give a more secure hold on delicate objects.

3. Double gloving. In aseptic environments, double gloving (a second pair worn over the first) reduces the risk of contamination (10). The standard protocol is to tuck the sleeves of the sterile garment into a second pair of sterile gloves, worn over the first pair, during gowning (10). Smooth gloves with anti-tack properties make donning and removal easier without compromising cleanroom specifications.

4. Regular glove replacement. Gloves must be replaced after critical interventions, on loss of integrity or after prolonged use, to maintain their integrity or aseptic conditions. Ambidextrous glove designs simplify frequent changes, which reduces workflow interruptions and minimises contamination risk.

C. Glove cost factors

The total cost of ownership (TCO) of cleanroom gloves goes beyond the initial purchase price and reflects their long-term value. Pharmaceutical companies are building ESG principles into their operations to meet regulatory and social requirements. For example, Amgen has built a sustainable manufacturing facility in Ohio, aligned with its environmental sustainability goals for 2027 (15). Novartis is committed to full carbon neutrality by 2030, in line with the objectives of the European Green Deal and US climate targets (16). Novo Nordisk has set targets to reach zero environmental impact by 2045 (17). ESG considerations therefore play an essential role in the selection of cleanroom gloves.

1. Environmental perspective. Effective disposal methods, such as recycling or downstream recycling, are consistent with the EU Waste Framework Directive (2008/98/EC) and the US Resource Conservation and Recovery Act (RCRA), minimising environmental impact (18-20). Environmentally sound production methods, such as energy-efficient processes and reduced CO? emissions, among others, support EU and US climate initiatives (21-23). For example, glove manufacturers that adopt renewable energy technologies and water-saving innovations contribute to regional and global sustainability goals.

2. Social considerations. Compliance with the EU Corporate Sustainability Reporting Directive (CSRD) and the US Fair Labor Standards Act (FLSA) supports ethical sourcing and fair labour practices (22, 24). Initiatives such as the Responsible Glove Alliance (RGA) also address workers’ rights in the glove manufacturing industry (25). Health and safety are equally paramount: adopting accelerator-free gloves reduces the risk of chemical exposure and allergic reactions, which supports occupational safety (26).

3. Governance. Supplier transparency is another crucial aspect of ESG criteria. The EU Corporate Sustainability Due Diligence Directive (CSDDD) requires companies to make sure that their suppliers meet ethical and environmental standards (27). Similarly, the climate disclosure rules of the US Securities and Exchange Commission (SEC) require transparency on ESG impacts, which promotes accountability (28).

End-user decision tree for glove selection

A decision tree designed as a table (Table 1) for the selection process brings together compliance, operational needs, material properties and ESG factors, allowing a systematic comparison of glove options from different suppliers.

To use this table, start by filling in the answers to each question. For each glove option, record the answer as “Yes” or “No”. Then filter out non-compliant gloves by excluding those that received a “No” at critical decision points. Finally, compare the remaining gloves, assessing them on performance, cost and fit with the ESG criteria to make the final selection.

Conclusion

Selecting cleanroom gloves for pharmaceutical manufacturing requires a balance between safety, functionality, regulatory compliance and sustainability. Nitrile gloves stand out as the preferred choice thanks to their hypoallergenic properties, chemical resistance and durability, while meeting strict regulatory standards. Compliance with ISO and ASTM standards ensures mechanical strength, microbial barrier efficacy and cleanliness. Adopting accelerator-free nitrile gloves further reduces allergen risks, in line with the EU REACH regulations.

By integrating ESG principles, such as sustainable manufacturing practices and ethical sourcing, manufacturers can strengthen both regulatory compliance and environmental stewardship. A structured decision-making approach that takes account of regulatory requirements, operational needs and sustainability goals enables pharmaceutical manufacturers to make informed, responsible glove choices, optimising performance and supporting the company’s broader sustainability initiatives.

Walid El Azab is an independent writer commissioned by O&M Halyard to write this article, and he writes independently of the company.

References

References

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