For the most part, the focus of our attention is on the Food and Drug Administration. However, another agency having extensive power to impact our working environment is the Occupational Safety and Health Administration (OSHA). It requires that all employees be provided a safe workplace by their employers. The regulation (29 CFR Part 1910, et al-Hazard Communications; Final Rule) encompasses the full range of activities performed within a life sciences organization, from research scientist to janitorial staff.
Employers are required to provide their employees with information about the potential dangers that may be encountered in the daily performance of their job. They are also required to provide employee training in terms of awareness and proper workplace safety. Engineering solutions to solve potential exposure problems are required when economically feasible.
The Material Safety Data Sheet, or MSDS, is used as a communications tool for suppliers to describe the materials they offer. This document defines the composition of the material and identifies hazards. The Chemical Manufacturers Association developed a standardized format for preparation of MSDS information called ANSI Z400.1. The manufacturer of the materials is required to provide the document upon request.
The company purchasing the product has the responsibility to collect and maintain MSDS information, for dissemination to employees. This task often becomes difficult, because the information is required to be readily available and in many cases, this means it is required to be in several locations throughout the facility. This a problem common to all types of facilities where materials move or are available in multiple locations. A simple example is copier toner, which in a large office setting would be located at several copier stations. Likewise, MSDS information must be readily accessible at each location where the material is used.
A paper system for maintaining the MSDS information is an invitation for problems because manufacturers will frequently incorporate changes to the information. Because the most current version of the MSDS is required, some means of tracking, collecting and replacing the paper copies at all possible locations must be developed. A company is in violation of the rules if the most current version is not in place, or differing versions are found in other areas.
Maintaining the MSDS information system needs to be taken seriously and requires identifying a point person responsible for receiving, developing and maintaining an internal communications network. Many companies offer the MSDS information in electronic formats, allowing data to be maintained within computer systems. Training is required so employees understand where the information is located and how to retrieve it. OSHA inspectors have been known to ask employees to do this during an inspection.
Within the life sciences, many companies create new materials from the raw materials they purchase. This is not limited to manufacturers, it is done routinely within hospitals and laboratories. If a new material is created, you are required to produce an MSDS. The information sheet should be blended into the information system that is maintained for purchased materials. There are several programs available that have templates consistent with the standard MSDS format. Simple programs can be purchased for less than $3,000.
Hank Rahe is director of technology at Contain-Tech in Indianapolis. He has over 30 years' experience in the healthcare industry, as well as four years in academia. He is an expert in the areas of conventional and advanced aseptic processing. He is the past chairman of the board of the International Society of Pharmaceutical Engineers, and is a member of the CleanRooms Editorial Advisory Board.