Cleanroom TN1000 Series 12" Nitrile Gloves (USP 797 & 800)

The Cleanroom TN1000 Series 12 nitrile gloves are positioned for use in pharmacy and cleanroom workflows aligned with USP <797> sterile compounding and USP <800> hazardous drug handling. In these environments, gloves serve two simultaneous roles: contamination control for aseptic work and barrier protection for operator safety.

Unlike general cleanroom manufacturing, USP environments are dominated by frequent hand contact, repeated glove disinfection, and defined change intervals. As a result, glove performance over time—fit, integrity, chemical compatibility, and residue behavior— has a direct impact on both product quality and operator exposure risk.

USP <797> emphasizes aseptic technique, defined hand hygiene, and controlled hand contact during sterile compounding. Gloves are expected to be clean, intact, appropriately disinfected, and changed at defined intervals to prevent contamination of critical sites and compounded sterile preparations.

USP <800> adds an additional layer of expectation: gloves must also protect the operator from hazardous drug exposure. This introduces additional stressors such as frequent alcohol disinfection, extended wear, and chemical contact—all of which can degrade glove performance if not properly managed.

Best practice begins with proper donning following hand hygiene and gowning SOPs. Gloves should be donned without snapping or over-stretching, which can compromise integrity. Once donned, gloves should be disinfected using an approved alcohol as defined by facility procedures, ensuring controlled wetness and adequate dry time before compounding activities resume.

Define and enforce glove change frequency. In USP <797> and <800> environments, gloves are commonly changed at regular time intervals, after leaving the compounding area, after contact with non-controlled surfaces, after spills, and whenever integrity is compromised. Extending glove use beyond defined limits is a frequent root cause of contamination events and hazardous drug exposure.

During hazardous drug handling, double-gloving or enhanced glove protocols may be required by SOP. In these cases, both inner and outer glove layers must be managed as part of the contamination and exposure control system—not treated independently.

Gloves are most effective when paired with controlled cleaning tools and solvents that support aseptic technique and controlled wetness during USP workflows.

• Suggested swab: Texwipe TX761 Alpha® Polyester Cleanroom Swab — supports controlled cleaning without excessive hand intrusion into critical areas.
• Suggested wiper: Texwipe TX1010 Vectra® Alpha® 10 Cleanroom Wiper — sealed-edge control for surface wipe-downs following compounding or spill response.
• Suggested solution: Texwipe TX167 Non-Sterile 70% IPA — commonly used for glove and surface disinfection when permitted by SOP (use sterile alcohols when required by procedure).

This Technical Vault content is provided for general operational guidance and procurement planning only. It does not replace USP requirements, facility SOPs, validation protocols, environmental monitoring programs, or manufacturer instructions. Always follow USP <797>, USP <800>, and site-specific procedures. Refer to current manufacturer documentation for glove performance, sterility, and chemical compatibility.