Disposable Cleanroom Garments in USP <795>, USP <797>, and USP <800>
A Technical Vault knowledge base article for smaller cleanrooms and compounding environments: practical selection logic, operational controls, and proper donning technique.
Key takeaways
- For many smaller operations, disposable garments reduce contamination variables and simplify compliance controls.
- Reusable (laundered) garment programs can perform well, but they require validated laundering, lifecycle management, segregation controls, and documentation that small sites often struggle to maintain consistently.
- In USP <800> hazardous drug handling, single-use apparel is frequently the most practical approach to minimize cross-contamination and exposure risk.
- Garment effectiveness depends on proper donning—technique is a primary control in every USP environment.
Purpose
This article provides a risk-based perspective on garment selection for smaller cleanrooms and compounding operations operating under USP <795> (nonsterile), USP <797> (sterile), and USP <800> (hazardous drugs). The intent is educational: to help customers understand why disposable cleanroom garments are often the most consistent and defensible strategy when resources, space, staffing, and documentation bandwidth are limited.
Why garments matter in controlled environments
Personnel are a major contamination source in controlled environments. Garments function as a barrier and a control measure intended to reduce particle and microbiological release from the operator, limit cross-contamination, and (in hazardous drug settings) help protect personnel from exposure. In practice, the strongest programs reduce variability and make correct behavior repeatable—especially for smaller sites with rotating roles and intermittent schedules.
Disposable vs. laundered garments: what changes for smaller cleanrooms
Reusable garments are not “set and forget.” A compliant reusable garment program is a process with multiple control points: qualification of the laundry provider, segregation of clean versus soiled apparel, inspection and retirement criteria, and lifecycle controls that ensure garments continue to perform over time. Larger organizations often have the scale, storage infrastructure, and quality systems to manage these controls. Smaller cleanrooms frequently do not.
Why disposable garments often perform better in small programs
- Fewer variables: no laundering variability, no garment aging decisions, no reuse tracking.
- Simpler training: standardized single-use donning reduces “workarounds” and inconsistency.
- Cleaner logistics: less storage complexity and clearer segregation (new in package vs. used/disposed).
- Reduced audit burden: fewer third-party controls to qualify and fewer records needed to defend continued garment performance.
Where reusable programs tend to break down (common failure points)
- Limited space to segregate clean storage from soiled collection.
- Inconsistent staff routines (especially when compounding is not daily).
- Lack of documented garment lifecycle limits, inspection criteria, and retirement triggers.
- Insufficient visibility into laundry controls and packaging practices.
Applying the logic to USP environments
USP chapters differ in their primary risk drivers. In simple terms: USP <795> emphasizes good practice for nonsterile compounding, USP <797> increases emphasis on sterile process control and repeatability, and USP <800> adds hazardous drug exposure control. Garment selection should follow the risk.
USP <795> (Nonsterile): practical garment strategy
Smaller nonsterile compounding areas often run intermittently and rely on multi-role personnel. Disposable garments are frequently the most straightforward way to establish consistent baseline cleanliness with minimal handling and storage complexity.
Best-fit scenarios for disposable garments
- Compounding is occasional or scheduled in short runs.
- Visitor/contractor traffic is common (service calls, equipment support).
- Storage space is limited and clean/soiled segregation is difficult.
USP <797> (Sterile): reduce variability, improve defensibility
Sterile compounding expectations place heavy weight on repeatability and control of contamination risk. For smaller cleanrooms, disposable garments often provide a clearer compliance story because they reduce lifecycle concerns (aging, requalification, wash limits) and remove laundering as a potential source of variability.
Why disposables are commonly preferred in small sterile programs
- Consistent baseline: each use begins with a fresh garment in controlled packaging.
- Fewer hidden failures: eliminates “looks fine” but degraded garments and uncertain service life.
- Simpler SOP enforcement: clear single-use boundaries reduce ambiguity and workarounds.
Note: Facilities should align garment selection with their internal risk assessment, facility design, and SOPs for gowning and aseptic technique.
USP <800> (Hazardous Drugs): single-use apparel reduces exposure risk
Hazardous drug handling introduces an additional requirement: protecting personnel and preventing hazardous residues from spreading beyond the compounding area. In smaller facilities, single-use garments are often the most practical approach because they reduce the risk of carrying residues into storage, laundering streams, or adjacent spaces.
Operational advantages of disposable garments in <800> settings
- Clear disposal pathway after use reduces unintended reuse.
- Minimizes the chance that hazardous residue is transported offsite for laundering.
- Simplifies training: “single-use and discard” is easier to audit and enforce than reuse programs.
Proper donning of disposable cleanroom garments
Donning technique is a primary contamination control. Even the best garment will underperform if it is donned incorrectly, handled roughly, or worn with gaps at cuffs and closures. The steps below are intended as a practical baseline; facilities should follow their approved SOPs and training requirements.
Before you begin
- Perform hand hygiene per facility SOP.
- Remove or secure personal items (jewelry, watches) per policy.
- Inspect garment packaging for integrity; do not use if compromised.
- Don in the designated gowning area; avoid donning inside the controlled workspace unless your SOP specifically permits it.
Recommended donning sequence
- Hair cover (bouffant or hood): Fully contain scalp hair and ears. Use a beard cover where applicable.
- Shoe covers or cleanroom boots: Put on before entering the controlled zone. Ensure full coverage and avoid stepping back into non-controlled areas after donning.
- Coverall/gown: Open carefully. Avoid shaking or snapping the garment. Step in without letting fabric touch the floor. Pull up by interior surfaces as much as possible.
- Closure and fit check: Fully zip/fasten. Confirm collar, wrists, and ankles are seated and comfortable. Avoid excessive readjustment that increases handling of exterior surfaces.
- Gloves (final step): Don gloves last. Pull glove cuffs over the garment sleeve cuff to maintain a continuous barrier. Change gloves immediately if torn or contaminated.
Common donning errors to avoid
- Allowing garments to touch the floor during donning.
- Leaving wrists exposed or wearing gloves under the sleeve cuff.
- Reusing disposable garments.
- Donning outside of controlled gowning areas and then moving into critical spaces.
Implementation checklist for smaller facilities
If you are standardizing on disposable garments, the operational goal is straightforward: make the correct process repeatable and easy to audit.
- Defined gowning area: Post the donning order and keep supplies staged to reduce handling and backtracking.
- Single-use policy: Establish clear “one entry / one use” rules where appropriate.
- Waste pathway: Provide labeled receptacles and disposal instructions (especially for USP <800> HD workflows).
- Training and observation: Periodically observe donning and correct common errors (cuffs, zipper closure, handling of exterior surfaces).
- Right-size inventory: Maintain sufficient stock to prevent rationing behaviors that lead to reuse.
References (standards and guidance)
The following standards and guidance documents are commonly used for establishing and supporting cleanroom operations, personnel gowning programs, and sterile/hazardous compounding practices. Always consult the official versions and apply them based on your facility’s risk assessment and SOPs.
- ISO 14644-1 — Cleanrooms and associated controlled environments — Classification of air cleanliness by particle concentration.
- ISO 14644-2 — Cleanrooms and associated controlled environments — Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration.
- ISO 14644-5 — Cleanrooms and associated controlled environments — Operations (includes gowning and personnel controls within operations programs).
- USP General Chapter <795> — Pharmaceutical Compounding—Nonsterile Preparations.
- USP General Chapter <797> — Pharmaceutical Compounding—Sterile Preparations.
- USP General Chapter <800> — Hazardous Drugs—Handling in Healthcare Settings.
- FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (CGMP).
- FDA CGMP regulations — 21 CFR Parts 210 and 211.
Disclaimer
This Technical Vault article is provided by SOSCleanroom for general educational use and operational planning only. It is not legal, regulatory, clinical, or safety advice, and it should not be treated as a statement of fact about your specific facility. SOSCleanroom does not certify compliance through this document. You are responsible for developing, approving, and maintaining your own SOPs, training, documentation, and validation based on the official USP–NF text, applicable state and federal requirements, and your internal quality systems.
Technical Vault — SOSCleanroom
© SOSCleanroom. All rights reserved.