What Are the Best Practices for Selecting Cleanroom Gloves?

Protecting the Process, Operator, and Product

Cleanroom gloves protect the products you manufacture from contaminants. Without a doubt, the cleanroom glove will interact with products and processes more than any other cleanroom consumable you purchase.

They must meet your internal specifications for cleanliness, be durable enough for hours of use, and be comfortable for your operators to wear. In some labor-intensive operations (e.g. medical device manufacturing), the technicians’ hands become the tools that assemble an operation’s product.

Particularly in these applications, selecting a glove that is both clean—to prevent product cross-contamination—and comfortable—to drive operator efficiency—is mission critical.

IEST Recommended Practice

IEST Working Group 5 is currently revising IEST-RP-CC005: Gloves and Finger Cots for Use in Cleanrooms and Other Controlled Environments. Document revisions will include a guidance summary for glove selection by cleanliness considerations, substrate material, and the extent of post-process washing to remove particles.

The document will also address many non-standard, in-house testing methods that operations develop and the inherent strengths and weaknesses of these tests. The appendix will include an expanded common cleanroom glove terminology section.

These updates are designed to assist the organization in developing a winning glove evaluation methodology that is repeatable and can be used to ensure that the selected manufacturer’s glove will meet/exceed your internal specifications. 

Performance Criteria

Gloves used in cleanrooms are available in these substrates:  PVC, Latex, and Nitrile (each with different performance characteristics). Regardless of cleanroom glove material, it is recommended that the cuff or gauntlet of the glove be long enough to cover the wrist area of the cleanroom operator so as not to contaminate the product, process, and cleanroom surfaces from exposed skin of the operator. In this regard, the glove cuff must be compatible in overlapping with the garment to effectively encapsulate operator-generated particles. 

All critical environment gloves should be packaged in a vacuum-sealed, double bag, with all the cuffs presented to one end. Disposable, powder-free nitrile, latex, or PVC cleanroom gloves are packaged 100 to a bag in two stacks of 50 each in cleanroom compatible bags and then placed in a box. When the bags are removed from the box, they should be wiped down with IPA before placing them in the gown room.

Cleanroom glove packaging is critical to ensuring cleanliness, dispensing, and donning requirements are met. It is impossible for an operator to properly don a powder-free nitrile glove packaged in a box without cross-contaminating the palm of the glove.  

As a companion product, reusable nylon glove liners may be worn and laundered at a cleanroom garment laundry using the same laundering specifications as for laundering cleanroom garments. Half-finger and full-finger glove liners enhance operator comfort and efficiency by absorbing hand perspiration, resulting in extended glove wear time.

Specification Process: Challenges and Solutions

Glove selection is based on the glove’s specific performance specifications in relation to the application, as well as the operator’s tactile sensitivity and comfort. That makes selecting the most appropriate glove for your facility a challenging trade-off between the most comfortable and cleanest glove.

Operators generally prefer a short cuff, ultra-thin glove that provides maximum tactile feedback and is less constrictive. The technical/quality team will want to specify a long cuff, thicker nitrile glove that has been through a rigorous post-process washing to remove surface contaminants left behind from the dipping process.

Testing Methods

The vendor(s) selected for gloves can provide test results for the suitability and durability of the gloves. These test results should include both physical properties and technical performance.

Physical properties that should be evaluated on all cleanroom gloves include:

• Palm width, weight, and length, according to IEST-RP-CC005.4 and ASTM D3767
• Tensile strength and elongation (both before and after aging), according to ASTM D412
• Thickness (at the cuff, palm, and fingertip), according to ASTM D3767

Technical performance attributes that should be evaluated on all cleanroom gloves include:

• Liquid particle counts, according to IEST-RP-CC005.4, Sec 16.4
• The non-volatile residue (with both DI water and IPA solutions), according to IEST-RP-CC005.4, Sec 17.2
• Fourier-transform infrared spectroscopy, according to IEST-RP-CC005.4, Sec 17.4
• Extractable counts (Ions), according to IEST-RP-CC005.4, Sec 17
• ESD properties (electrostatic decay, surface resistivity and triboelectric charge), according to ANSI/ESD SP15.1

As testing and detection methods improve, the presence of glove additives and their potential adverse consequences are becoming more apparent. Scanning Electron Microscopy with Energy Dispersive X-Ray Analysis (SEM-EDX) is becoming an industry best practice for glove manufacturers—this enhanced level of detection provides elemental analysis and chemical characterizations of particles detected on glove surfaces.

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