Cleanroom Glove Selection Guide USP 795 797 800

Cleanroom & Compounding Glove User Guide

Gloves are the most frequently changed interface in controlled environments. Selection and technique directly influence particulate control, hygiene performance, aseptic assurance, and hazardous drug exposure prevention. This guide consolidates common decision points customers use when selecting glove type, packaging format, and gowning practices.

1) Glove Selection Framework (Risk-Based)

Select gloves based on the dominant risk(s) in your process—particulates/residues, microbial control, chemical exposure, and/or electrostatic discharge (ESD). No single glove is optimal for all environments.

• Particulates / residues: prioritize controlled manufacturing, low particle shedding, and low extractables.
• Microbial control: use sterile gloves and aseptic donning for aseptic processing and sterile compounding.
• Chemical / HD exposure: use chemotherapy-tested gloves for hazardous drug handling; double-gloving is commonly specified.
• ESD control: use ESD-dissipative gloves when required by your facility’s ESD control plan.

2) USP <795> — Nonsterile Compounding (Boxed Gloves Context)

USP <795> focuses on nonsterile compounding. Sterile gloves are not required; the emphasis is on hygiene, prevention of cross-contamination, and consistent technique under SOP control.

• Can boxed gloves be used? Yes—boxed, non-sterile gloves can be appropriate when managed by SOPs.
• What auditors look for: glove suitability, box storage/handling, glove-change triggers, and training discipline.
• Material preference: latex-free nitrile is commonly preferred to reduce allergen and variability risk.

Example boxed glove often used in USP <795> workflows (non-sterile, boxed) when SOP-controlled: Kimtech Polaris Nitrile Exam Gloves.

3) USP <797> — Sterile Compounding (Aseptic Expectations)

USP <797> governs sterile compounding. Sterile gloves and aseptic technique are mandatory, and glove selection must support validated gowning procedures and routine glove disinfection during operations.

• Sterile gloves: required; pair-packed formats support cleaner aseptic donning.
• Technique: gloves are disinfected routinely during work; replace at defined intervals or immediately if compromised.
• System view: integrate gloves into a complete aseptic program (garments, training, observation, documentation).

Example sterile glove for higher-grade environments: Ansell BioClean EXS Sterile Nitrile Gloves (ISO 4 / Class 10).

4) USP <800> — Hazardous Drugs (HD) Handling

USP <800> addresses worker and environmental protection for hazardous drugs and applies in addition to USP <795> or USP <797> (it does not replace them). Glove selection must align with hazardous drug exposure risk and your facility’s SOPs.

• Glove testing: hazardous drug programs typically specify powder-free chemotherapy gloves tested to ASTM D6978.
• Double-gloving: frequently specified; outer gloves are changed more often and whenever contamination is suspected.
• Overlay reality: if work is sterile and hazardous, facilities commonly manage both USP <797> aseptic expectations and USP <800> exposure controls simultaneously.

5) ISO 14644 Addendum (Classification, Monitoring, Operations)

Many compounding and cleanroom programs reference ISO standards as the operational backbone for contamination control. ISO does not mandate specific glove models; it defines how cleanrooms are classified, monitored, and controlled through documented operational discipline.

Quick ISO Reference (Commonly Cited Limits at ≥0.5 µm)

The table below summarizes commonly referenced ISO 14644-1 airborne particle limits at ≥0.5 µm. Facilities should confirm the classification basis used in their qualification and SOPs.

ISO Class	Max particles/m³ (≥0.5 µm)	Typical use context
ISO 5	3,520	Critical-zone operations (aseptic work areas)
ISO 7	352,000	Cleanroom background / controlled support areas
ISO 8	3,520,000	Ante/support spaces with controlled practices

6) EU GMP Annex 1 (Secondary Reference)

EU GMP Annex 1 is an aseptic manufacturing framework. Many organizations reference Annex 1 as a benchmark because it emphasizes contamination control strategy (CCS), operator behavior, and continuous improvement. In practice, Annex 1 discipline aligns most closely with USP <797> sterile/aseptic programs.

7) Proper Donning (Gowning) and Cuff Interface Control

Donning technique is a procedural control. The glove-to-sleeve interface is a recognized contamination pathway in controlled environments. Facilities should train and periodically observe operators to confirm the sequence and interface details—not just the glove brand.

Placement requirement: Gloves should be worn over the cuff of the garment (lab coat, smock, or full suit). Wearing gloves under cuffs can expose garment material and increase contamination risk.

8) Product Pointers (Examples by Use Case)

Use case	Example product links	How to position
USP <795> boxed glove program	Kimtech Polaris Nitrile Exam Gloves	Non-sterile boxed glove option when SOP-controlled (hand hygiene, box management, change frequency).
ISO 5 / Class 100 cleanroom (non-sterile)	Ansell 93-311 Nitrilite (ISO 5) Ansell CE5-755 Microflex (ISO 5)	Cleanroom-processed nitrile options often chosen where particulate control expectations are higher than standard exam glove use.
Aseptic / sterile glove program (USP <797> / Annex 1)	Ansell BioClean EXS Sterile Nitrile (ISO 4)	Sterile gloves are required; integrate with aseptic donning and routine glove disinfection practices.
Latex exam glove (special considerations)	Ansell 69-318 TouchNTuff Latex Gloves	Use only where latex sensitivity/allergen risk is assessed and formally accepted; nitrile is often preferred in regulated environments.

9) Reference Points (How We Verify Guidance)

Where requirements vary by state board, facility risk assessment, or compounding category, confirm your SOPs against the official USP–NF text and regulator expectations. The reference points below are the same items quality teams typically use when double-checking glove decisions.

• USP <795>: nonsterile compounding controls, hygiene practices, cross-contamination prevention.
• USP <797>: sterile compounding, aseptic technique, sterile glove requirements, environmental controls.
• USP <800>: hazardous drug exposure controls, PPE selection, workflow containment practices.
• ISO 14644-1/2/5: classification basis, monitoring plan concepts, operations control program expectations.
• EU GMP Annex 1 (secondary): contamination control strategy (CCS) discipline and aseptic behaviors.
• ASTM D6978 (as applicable): chemotherapy glove testing commonly referenced for hazardous drug handling programs.
• Manufacturer documentation: technical data sheets, quality statements, intended-use guidance, and lot traceability.