This Manual Chapter establishes the policy to implement uniform guidelines and procedures for the placement, maintenance, use and inspection of emergency eyewash, facewash, and emergency shower equipment in International Organization for Standardization (ISO) Class 8, or better, classified areas of APFs engaged in the production and/or testing of sterile and non-sterile drugs, pharmaceuticals, and biologics for human use.

The intent of this policy is to maximize worker protection beyond what is afforded by required Personal Protective Equipment (PPE). This is accomplished by providing access to secondary eyewash equipment, as well as minimizing patient risk due to contamination of aseptic processing areas from non-sterile discharges from potable water valves and drains.

Emergency flushing systems for the eye, face, or body are NOT a substitute for the use and proper maintenance of personal protective equipment (PPE) or for the safe and proper handling of potentially hazardous materials.

This Manual Chapter applies to Aseptic Processing Facilities (APFs) engaged in the production and/or testing of sterile and non-sterile drugs using aseptic processes, inclusive of pharmaceuticals and biologics for human use, in NIH owned and leased facilities.  

Also included in the scope are training requirements for staff engaged with the production of products in APFs; the staff/contractors engaged in cleaning APFs; as well as the staff/contractors providing operations and maintenance services to support the APFs.

The U.S. Code of Federal Regulations, 29 CFR 1910.151 states, “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.”

The NIH APFs will provide equivalent worker protection for potential exposures to injurious corrosive materials, based on risk assessments that take into consideration existing  regulations, to minimize sources of waterborne environmental contamination in order to maintain aseptic classified environments used to produce cellular therapeutics for humans: 

1. Excluding plumbed emergency eyewashes, facewashes, and showers, within APF, ISO-8, or better, classified areas;
2. Ensuring other areas of APF’s conform to the requirements of the current ANSI/ISEA Z358.1 standard;
3. Providing sterile, sealed, dual eyewash bottle stations in APF, ISO-8, or better, classified areas;  
4. Providing a conventional, plumbed emergency eyewash/facewash and showers, as required, as close to the point of entry/exit from the APF’s ISO classified areas as practicable; and by
5. Periodically reviewing Standard Operating Procedures, to ensure that operations such as cleaning and decontamination are to be performed in a manner that minimizes splash risk to workers performing these operations.

The NIH will also comply with OSHA standards for workers exposed to injurious corrosive materials, using a combination of strict administrative controls for use of PPE, and both an awareness of and a demonstrated competency to respond to an adverse exposure using portable eye wash stations inside the ISO-8 and 7 areas; guiding the exposed worker through the APF to the nearest plumbed emergency eyewash/shower station, and the proper use of this equipment.

Emergency eyewash, shower and related equipment is not a substitute for proper administrative controls or strict adherence to the use of approved personal protective equipment (PPE). 

All personnel working in areas where emergency eyewash, shower or related equipment is located will wear approved eyewear and (as directed) protective clothing/coverings; and follow all Standard Operating Procedures that have been developed to ensure the safety of all personnel working in these areas.

1. The Quality Assurance Director or Manager within each APFs is responsible for:
   1. Ensuring the Quality Assurance (QA) Officer reviews and approves the location type, and installation of eye/face wash fixtures and stations; and
   2. Ensuring the APF Production staff track the expiration date on the sealed bottles to ensure they are replaced prior to that date, and for daily inspection of fixtures and stations to ensure their fitness for use.
2. The Office of Research Services (ORS), Division of Occupational Health and Safety (DOHS) is responsible for reviewing the use of Self-Contained Eye/Facewash Fixtures or Secondary Two-Bottle Eyewash Stations Options identified in Appendix 2 - Emergency Eyewash Equipment Selection and Placement Options.
3. The Director, Office of Research Facilities Development and Operations (ORFDO), has the overall responsibility for design, construction, operation, maintenance, renovation and decommissioning of NIH facilities.
4. The ORFDO, Division of Technical Resources (DTR) is responsible for:
   1. Reviewing design and construction documents associated with APFs; and for
   2. Conducting inspection of APFs for compliance with this policy.
5. The ORFDO, Division of Facilities Operations and Management (DFOM) is responsible for the installation of new emergency eyewash/facewash fixtures and stations when authorized.
6. The ORFDO, Division of Design, Construction and Management (DDCM) is responsible for the installation and/or removal of eyewash/facewash fixtures and stations that are part of a construction project.
7. The ORS, Office of Scientific Resources (SR), has overall responsibility for occupational safety and health of NIH facilities.
8. The ORS, DOHS is responsible for reviewing and approving design and construction submittals associated with this policy.

1. Eye/Face Exposure Event Response Within the Classified Area of an APF where a Secondary Two-Bottle Eye/Facewash Station is provided:
   1. Stop all work. All employees must work in groups of at least two trained personnel during cleaning operations.  No employee should be alone in an area where these stations are required;
   2. Unexposed worker shall guide and assist the exposed worker to the nearest bottle-mounted fixture or plumbed emergency eyewash/shower station;   
   3. Commence flushing contaminated skin and/or mucous membranes per SOP;
      1. Begin flushing the affected area of the body immediately
      2. For chemical spills to the eye(s), hold eyes open as wide as possible to permit the water to reach all areas around the eye
      3. Unexposed worker may be needed to assist with holding eye(s) open and/or ensuring that flushing solution is directed to affected eye(s)
      4. Unexposed worker shall hold open any doors between the site of the incident and the nearest plumbed emergency eyewash/shower station, providing the employee a clear, unobstructed pathway to the station, and
   4. The unexposed worker shall call for assistance, as specified in Standard Operating Procedure (SOP) for the APF. This shall include notifying Occupational Medical Service (OMS) or activating the  NIH Division of Fire and Rescue Services (DFRS) Emergency Medical System (EMS), by dialing 911 from a house phone or (301) 4596-5685 using a cell phone. This notification shall be included in the incident SOP for the APF. This includes paging OMS after normal business hours and activating EMS via a landline or cell phone.
2. Eye/Face Exposure Event Response outside of the ISO 8/7 areas where a plumbed emergency eyewash/shower station is provided:  
   1. Unexposed worker, who has guided the exposed worker through the portals will assist the exposed worker at the eyewash station/emergency shower.
   2. Once at a plumbed station, exposed employee shall continue to flush the affected area of the body for a minimum of 15 minutes or until EMS or OMS has assumed responsibility for treatment of exposed worker.
   3. EMS/OMS shall take over care and decontamination of the exposed worker, continuing to flush and remove contaminated/potentially contaminated PPE under the emergency shower, per SOP.
   4. As required, the unexposed worker shall initiate further actions per the Clinical Center (CC) Hazardous Spill Management Policy.

1. NIH Policy Manual, Chapter 1743 Keeping and Destroying Records, available at: https://oma1.od.nih.gov/manualchapters/management/1743/
2. NIH Design Requirements Manual, available at: https://www.orf.od.nih.gov/PoliciesAndGuidelines/BiomedicalandAnimalResearchFacilitiesDesignPoliciesandGuidelines/Pages/default.aspx, Chapter 13
3. U.S. - Code of Federal Regulations Title 21 , available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211&showFR=1
4. 21 CFR Part 1271, Section 361 - Minimal Manipulation of Human Cells, Tissues, and Cellular Tissue-Based Products  
5. 21 CFR Part 1271 Section 351 - More Than Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products, and products not subject to Human Cells, Tissues, and cellular and tissue-based Products (HCT/P)
6.  U.S. Code of Federal Regulations 29 CFR 1901.151, Occupational Safety and Health Standards, available at https://www.osha.gov/laws-regs/regulations/standardnumber/1910h
7. American National Standards Organization (ANSI)/International Safety Equipment Association - ANSI/ISEA Z358.1 and ANSI/ISEA Z87.1, available at: https://webstore.ansi.org/RecordDetail.aspx?sku=ANSI%2fISEA+Z358.1+%2f+ANSI%2fISEA+Z87.1+-+Eyewash+and+Eye+Protection+Package
8. International Organization for Standardization (ISO) – ISO 14644 Cleanrooms and associated controlled environments, available at: https://www.iso.org/standard/53394.html
9. Standard Operating Procedures (SOP) for APF Cleaning Contractors (Available by request on an as needed basis. Contact the Office of Research Support and Compliance @ http://intranet.cc.nih.gov/orsc/index.html for assistance).
10. Clinical Center (CC) Hazardous Spill Management Policy S-010

1. Aseptic Processing Facility (APF): Facilities which produce drug and/or biologic products for human injection, vascular infusion, implantation, ingestion, inhalation, or absorption. This includes facilities where non-aseptic products are produced using aseptic practices.
2. ISO Classified Space: These spaces must satisfy the Food and Drug Administration (FDA), United States Department of Health and Human Services (HHS) requirements for the work being performed. ISO classified spaces are areas where HVAC systems are specifically designed to reduce airborne contaminants below a specified level (as defined in ISO classes) and both temperature and relative humidity (RH) are controlled more tightly than in the ambient environment. These areas must be performance verified/qualified to meet the requirements of ISO Classification, specifically for Class-8, 7, or 5.
3. Conventionally Plumbed Emergency Fixture: �May reference eyewash, facewash, emergency shower, and combination fixtures which conform to the normally applicable DRM, ABA/ADA, OSHA, and NIOSH requirements for placement, capacity, and function. These fixtures are tested weekly, releasing potable water, and constitute a known environmental risk of contamination to ISO Classified spaces.
4. Globally Harmonized System of Classification and Labelling of Chemicals (GHS): Is a system developed by the United Nations for standardizing and harmonizing the classification and labelling of chemicals globally. More specifically, the UN GHS Document (known as UN GHS Purple Book) which defines physical, health and environmental hazards of chemicals and harmonizes classification criteria; and standardizes the content and format of chemical labels and Safety Data Sheets.
5. Injurious corrosives: Chemicals, upon eye exposure resulting in serious eye damage that doesn't heal in 20+ days, shall be designated with pictograms and labels as described in Global Harmonized System, specifically. Serious eye damage products are labeled "Danger."
6. Irritant: Chemicals, upon eye exposure resulting in serious eye damage that heals quickly, shall be designated with pictograms and labels as described in Global Harmonizing System,specifically.Irritant eye damage products are labeleded "Caution."
7. ISO Class: An air quality classification from the International Organization for Standardization, per ISO 14644-1 standards, which specify the cleanliness of spaces by airborne particulate via decimal logarithm of the number of particles 0.1 μm or larger permitted per cubic meter of air.
8. Secondary Two-Bottle Eye/Facewash Station: A bracket and holder with a minimum of two (2) sealed bottles, 946 ml (32 oz.) or larger each of preserved water, preserved buffered saline solution or other medically acceptable flushing solution.