Cleanroom safety across various types of industries and settings can be a complicated matter. The common thread between all is that they must comply with applicable U.S. Department of Labor (DOL) Occupational Safety and Health Administration (OSHA) regulations. A facility manager’s task is to decide which requirements apply to his or her operation, and what particular segment of their operation crosses over or intersects with the specific industry standard that may apply at any given point of their daily operations. This article will cover the major OSHA industry standard that may apply to most, if not all, cleanroom operations contained in the Code of Federal Regulations (CFR) 29 CFR. This standard is referred to as the General Industry Standard, 29 CFR 1910. Your cleanroom may fall under a different standard so ensure that you consult with the applicable standard contained in 29 CFR before you refer to 29 CFR 1910, as those requirements may supersede those contained in 1910.
Cleanroom environments have established industry guidelines to ensure that the highest product quality guidelines are adhered to in order for their business model to thrive. Is the same emphasis placed on worker safety in your cleanroom? Let’s explore the primary components that a typical cleanroom may need to adhere to while conducting their work.
Minimum requirements per 29 CFR
All cleanroom facilities must have at a minimum per 29 CFR: the OSHA poster, OSHA 300 log, medical services and first aid, and exit routes, emergency action plans, and fire prevention plans.
OSHA poster: “Job Safety and Health: It’s the Law” (2013) prominently displayed in the facility informs workers of their rights under the Occupational Health and Safety Act.
OSHA 3000 log: Employers with more than ten employees and whose establishments are not classified as a partially exempt industry must record work-related injuries and illnesses using OSHA Forms 300, 300A, and 301. Covered employers are required to prepare and maintain records of serious occupational injuries and illnesses using the OSHA 300 Log.
Medical services and first aid: The employer shall ensure the ready availability of medical personnel for advice and consultation on matters of plant health. In the absence of an infirmary, clinic, or hospital in near proximity to the workplace which is used for the treatment of all injured employees, a person or persons shall be adequately trained to render first aid. Adequate first aid supplies shall be readily available. 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.
Exit routes, emergency action plans, and fire prevention plans: The use of floor plans or workplace maps should clearly show the emergency escape routes that should be included in the emergency action plan. The emergency action plan should address emergencies that the employer may reasonably expect in the workplace. Examples are fire, toxic chemical releases, hurricanes, tornadoes, blizzards, floods, and others. An emergency action plan must be in writing, kept in the workplace, and available to employees for review. An emergency action plan must include at a minimum:
• Procedures for reporting a fire or other emergency
• Procedures for emergency evacuation, including type of evacuation and exit route assignments
• Procedures to be followed by employees who remain to operate critical plant operations before they evacuate
• Procedures to account for all employees after evacuation
• Procedures to be followed by employees performing rescue or medical duties
• The name or job title of every employee who may be contacted by employees who need more information about the plan or an explanation of their duties under the plan.
• An employer must designate and train employees to assist in a safe and orderly evacuation of other employees.
Fire prevention plans: The standard calls for the control of accumulations of flammable and combustible waste materials. A fire prevention plan must be in writing, be kept in the workplace, and be made available to employees for review. However, an employer with 10 or fewer employees may communicate the plan orally to employees. A fire prevention plan must include: A list of all major fire hazards, proper handling and storage procedures for hazardous materials, potential ignition sources and their control, and the type of fire protection equipment necessary to control each major hazard; procedures to control accumulations of flammable and combustible waste materials; procedures for regular maintenance of safeguards installed on heat-producing equipment to prevent the accidental ignition of combustible materials; the name or job title of employees responsible for maintaining equipment to prevent or control sources of ignition or fires; and the name or job title of employees responsible for the control of fuel source hazards.
Fire protection: Contains requirements for fire brigades and all portable and fixed fire suppression equipment, fire detection systems, and fire or employee alarm systems installed to meet the fire protection requirements of 29 CFR Part 1910.
Other applicable sections of the standard
Occupational health and environmental control: Ventilation—Exhaust ventilation system: A system for removing contaminated air from a space, comprising two or more of the following elements: (a) enclosure or hood, (b) duct work, (c) dust collecting equipment, (d) exhauster, and (e) discharge stack. Occupational noise exposure—The employer shall administer a continuing, effective hearing conservation program, as described in paragraphs (c) through (o) of this section, whenever employee noise exposures equal or exceed an 8-hour time-weighted average sound level (TWA) of 85 decibels measured on the A scale (slow response) or, equivalently, a dose of fifty percent. For purposes of the hearing conservation program, employee noise exposures shall be computed in accordance with appendix A and Table G-16a, and without regard to any attenuation provided by the use of personal protective equipment.
Hazardous materials: Inspection of compressed gas cylinders—Each employer shall determine that compressed gas cylinders under his/her control are in a safe condition to the extent that this can be determined by visual inspection. Visual and other inspections shall be conducted as prescribed in the Hazardous Materials Regulations of the Department of Transportation (49 CFR parts 171-179 and 14 CFR part 103). Where those regulations are not applicable, visual and other inspections shall be conducted in accordance with Compressed Gas Association Pamphlets C-6-1968 and C-8-1962, which is incorporated by reference as specified in Sec. 1910.6. Flammable liquids— Flammable liquid means any liquid having a flashpoint at or below 199.4 °F (93 °C). Hazardous Materials – 1910.119 App A List of Highly Hazardous Chemicals, Toxics and Reactives (mandatory). This Appendix contains a listing of toxic and reactive highly hazardous chemicals which present a potential for a catastrophic event at or above the threshold quantity.
Toxic and hazardous substances/air contaminants: 1910.100 Subpart Z: An employee’s exposure to any substance listed in Tables Z-1, Z-2, or Z-3 of this section shall be limited in accordance with the requirements. To achieve compliance with paragraphs (a) through (d) of this section, administrative or engineering controls must first be determined and implemented whenever feasible. When such controls are not feasible to achieve full compliance, protective equipment or any other protective measures shall be used to keep the exposure of employees to air contaminants within the limits prescribed in this section. Any equipment and/or technical measures used for this purpose must be approved for each particular use by a competent industrial hygienist or other technically qualified person. Whenever respirators are used, their use shall comply with 1910.134.
Personal protective equipment: Application—Protective equipment, including personal protective equipment for eyes, face, head, and extremities, protective clothing, respiratory devices, and protective shields and barriers, shall be provided, used, and maintained in a sanitary and reliable condition wherever it is necessary by reason of hazards of processes or environment, chemical hazards, radiological hazards, or mechanical irritants encountered in a manner capable of causing injury or impairment in the function of any part of the body through absorption, inhalation, or physical contact.
Materials handling and storage: Use of mechanical equipment—Where mechanical handling equipment is used, sufficient safe clearances shall be allowed for aisles, at loading docks, through doorways, and wherever turns or passage must be made. Aisles and passageways shall be kept clear and in good repair, with no obstruction across or in aisles that could create a hazard. Permanent aisles and passageways shall be appropriately marked. Secure storage— Storage of material shall not create a hazard. Bags, containers, bundles, etc., stored in tiers shall be stacked, blocked, interlocked, and limited in height so that they are stable and secure against sliding or collapse.
Hazard communication/GHS: The following text for 1910.1200 has been updated to align with the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Revision 3, issued in the Federal Register, March 26, 2012. This rule became effective May 25, 2012. The purpose of this section is to ensure that the hazards of all chemicals produced or imported are classified, and that information concerning the classified hazards is transmitted to employers and employees. The requirements of this section are intended to be consistent with the provisions of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS), Revision 3. The transmittal of information is to be accomplished by means of comprehensive hazard communication programs, which are to include container labeling and other forms of warning, safety data sheets, and employee training.
Occupational exposure to hazardous chemicals in laboratories: “Laboratory” means a facility where the “laboratory use of hazardous chemicals” occurs. It is a workplace where relatively small quantities of hazardous chemicals are used on a non-production basis. “Laboratory use of hazardous chemicals” means handling or use of such chemicals in which all of the following conditions are met:
(i) Chemical manipulations are carried out on a “laboratory scale;”
(ii) Multiple chemical procedures or chemicals are used;
(iii) The procedures involved are not part of a production process, nor in any way simulate a production process; and
(iv) “Protective laboratory practices and equipment” are available and in common use to minimize the potential for employee exposure to hazardous chemicals.
Other standards that may apply in your facility may include, but are not limited to: electrical safety, lock-out/tag-out, compressed gas/air and equipment, machinery and machine guarding, fall protection etc. Please consult OSHA standards for additional information and requirements as this article is not intended to capture all OSHA standards and requirements.
In summarizing these complex regulatory requirements, one should always consult with the OSHA standards in its entirety before implementing a cleanroom safety program. Another great source of information and assistance may be provided by your insurance broker or carrier. Whether you are a beginner tasked with setting up a safety program, or an expert in the field looking to build upon your existing safety program, it’s always critical to follow OSHA standards and rely upon your OSHA 300 log, Insurance Carrier Loss Control data to determine how your organization is performing while protecting your most important asset—your employees.
If you are concerned with your employees’ safety, fearful of a costly and embarrassing OSHA inspection, or worse escalating employee incident/illness/injury rates and/or expensive business interruptions, contact a professional to assist.
The author thanks Ken Brousseau, Operations Manager of Kinetics Corp. in Eschau-Hobbach, Germany, for his assistance with this article. http://kinetics.net
Randall Charpentier is the President/Principal Consultant with HealthSafe New England, a wholly owned safety and risk management consulting firm located in the Northeastern U.S. As a 20-year experienced professional consultant, his cleanroom project experience ranges from leading teams on the construction of the West Coast space shuttle project, electronics manufacturing, bio-pharmaceutical/life sciences facilities, and reducing/eliminating exposures/hazards for leading biomedical research/teaching hospitals. firstname.lastname@example.org, www.hsnellc.com
This article appeared in the October 2014 issue of Controlled Environments.