Occupational Hazards
in Cleanrooms
Acquiring expertise on proper aseptic processes that significantly enhance the quality of your compounding practices and the safety of your CSPs.
Introduction:
Safety within cleanroom environments is everyone’s responsibility. There are inherent risks associated with sterile compounding, which are often underestimated or ignored. Employee safety recommendations are embedded in USP <800>. These hazards are unavoidable in order to provide life-saving compounds to patients. However, occupational hazards linked to compounding are not only present in hazardous drug (HD) compounding. Safety is paramount in the world of compounding, whether it be patient, medication, or occupational. There are many other hazards and risks associated with simply working in cleanroom environments. A few of them are discussed in the body of this article.
1. Eye Accidents
During his tenure as a sterile admixtures supervisor, the author witnessed two notable incidents involving accidental exposure to the eyes. In one case, an employee was compounding a preparation that included Mesna as a component. Due to the application of excessive positive air pressure to the vial, the concentrated solution sprayed outward when the needle was withdrawn from the vial septum, resulting in direct contact with the employee’s face and eyes. In a state of distress, the employee bypassed the recommended protocol by proceeding directly to employee health without first utilizing the eyewash station or consulting the Safety Data Sheet (SDS) for appropriate guidance. As a result, the employee sustained temporary eye damage and required several days of medical leave.. Under federal workplace safety regulations (OSHA), the location of an emergency eyewash station is guided by ANSI/ISEA Z358.1 (referenced by OSHA in enforcement).
The key requirements are:
- Eyewash stations must be located within a 10-second walk (about 55 feet) of the hazard.
- Paths must be unobstructed — no stairs, doors that require opening, or other barriers in the way.
- Same level as the hazard — no climbing or descending to reach it.
- Well-lit and marked with a visible sign.
- Kept in ready-to-use condition and not blocked by storage, carts, or equipment
The ANSI standard (see commentary below) also specifies that the water must be tepid (60–100°F) and capable of flowing for at least 15 continuous minutes. Additionally, eye wash water must be allowed to run weekly for about 4 -5 minutes to rinse off potentially harmful chemicals and sediments found in stagnant pipeline water.
Other essential safety concepts include training the staff on recognizing eye and other injuries by reading the peer’s gestures and intervening swiftly by leading the injured and potentially blinded peer by the hand to the eye wash station, and ensuring adequate rinse time is achieved before seeking medical care.
2. Inhalation Hazards
Inhalation hazards are real in sterile compounding environments, and they include:
Cleaners and disinfectants. With the requirement for the use of sporicidal disinfectants to control spores in cleanrooms comes the associated hazards of routine disinfection. Inhalation exposure risk increases with the use of organic acid-containing sporicidal disinfectants, such as peracetic acid. These chemistries are irritants to the employee’s airways, eyes, and skin. Respirators and eye protection are a must, especially when applying these disinfectants to cleanroom ceilings. Vapor mitigation strategies include using only enough liquid to saturate pads and wipers, rather than flooding them with excessive amounts. Additionally, used wiper vapors can be contained by disposing of them in zip-lock bags.
3. Hazardous drug (HD) Compounding
Mixing HD already poses many inherent risks, as it involves both aseptic mixing and safe mixing to prevent HD contamination of adjacent areas. Most of the time, containment breaches occur during doffing and departure from the HD buffer. We tend to focus more on properly gowning to enter the HD buffer and BSC, but we may not follow the proper doffing sequence, starting with the removal of the most critical outer glove within the BSC. Occupational exposure here is a function of how contaminated work areas are, the number of HD compounding days an employee is scheduled to work in these areas, and how well HD waste is handled, to name a few (see “ALARA” principle often referred to in nuclear medicine settings and RAD exposure levels). Inhalation risks are also inherent in the compounding of hazardous drugs (HDs). Here, volatile agent vapors can be mitigated with the use of supplemental engineering controls or closed system transfer devices (CSTDs).
4. Horizontal Hood Mixing of Antibiotics and Drug Allergies
To a person severely allergic to any antibiotics, this activity may pose a moderate risk depending on aseptic manipulation of vials and the use of pressures during withdrawing and transferring component solutions. Utilizing slight negative pressure during all compounding manipulations may help mitigate this risk significantly.
5. Physical Injury
These include, but are not limited to, injuries during lifting, squatting, reaching, frequent hand movements, poor ergonomics, and others. Facilities conduct routine safety and “environment of care” inspections to ascertain that patients, visitors, and employees are as safe as possible during operations and address hazards. In cleanroom operations, an employee may be required to perform specific physical tasks as part of their job description, such as lifting a maximum of 30 lbs. or standing for long periods. Employees who are unable to meet the physical requirements of their jobs must work with their employer’s Human Resources and Occupational Health departments to request accommodations, if applicable.
6. Psychological
Claustrophobia (open vs. closed cleanroom configurations), gown and double gown tolerance, and tobacco addiction may prevent an employee from working in a calm state to focus on form, function, and job safety. Consistent attention to monitoring of temperature and humidity ranges, and even noise levels in cleanrooms, creates optimal working conditions, job satisfaction, and overall well-being.
Conclusion
Several hazards associated with cleanroom work were addressed. Whether stocking, compounding, cleaning/disinfecting, or working with heavy equipment, such as laminar hoods, there will be risks that must be addressed. Employees and designated persons (DPs) are to be vigilant of hazards and working conditions in their immediate work areas. Employee training in the handling of emergencies and injuries is critical for overall job safety.
References
OSHA Interpretation Letter – 10-Second Rule. In a 1992 OSHA interpretation letter, the Agency clarified the application of 29 CFR 1910.151(c) and referenced ANSI Z358.1-1990 for more specific requirements…”
- OSHA (Occupational Safety and Health Administration) 29 CFR 1910.151(c) sets the legal requirement.
- ANSI (American National Standards Institute) — Z358.1-2021 Section 4.5.2 gives the industry standard: ≤10 seconds, same level, unobstructed, clearly marked, well-lit.
Commentary and footnotes:
Under federal workplace safety regulations (OSHA), the location of an emergency eyewash station is guided by ANSI/ISEA Z358.1 (referenced by OSHA in enforcement).
OSHA
29 CFR 1910.151(c) Medical services and first aid
“Where the eyes or body of any person may be exposed to injurious corrosive materials, suitable facilities for quick drenching or flushing of the eyes and body shall be provided within the work area for immediate emergency use.”
- OSHA does not define “immediate” in seconds or feet — instead, it enforces this through the ANSI standard.
- OSHA interpretation letters confirm that they use ANSI/ISEA Z358.1 as the accepted best practice for compliance.
- Example: OSHA Standard Interpretation, “Eyewash and shower facilities” (November 1, 2002).
ANSI
- ANSI/ISEA Z358.1-2021 (Emergency Eyewash and Shower Equipment) — Section 4.5.2 (Eyewash location requirement)
“The location of the eyewash equipment shall be on the same level as the hazard, with the path of travel from the hazard to the equipment requiring no more than 10 seconds. The location shall be free of obstructions and shall be located in a well-lit area identified with an obvious sign.”
- Notes in ANSI clarify that 10 seconds ≈ , 55 feet is the standard distance for most workers, but shorter distances may be required if the chemical is highly corrosive or hazardous to the eyes.
Released August 2025
About the Author
Luis Hernandez, RPh, BCSCP, is a certified sterile compounding pharmacist and the founder of Seven97 Training Solutions. Dedicated to advancing USP 797 pharmaceutical training, validation, and certification, Luis aims to promote and inspire excellence in aseptic processing, medication and patient safety, and regulatory compliance.