In this podcast, Dean Calhoun discusses Industrial Hygiene in the Pharmaceutical Industry.
[Note: These are the podcast show notes, not a complete transcript of the actual podcast.]
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Discuss episode number 9
Mention main topic for today, “Industrial hygiene in the pharmaceutical industry.”
Discuss upcoming events of importance to environmental, health and safety professionals in the BioPharma Industry.
Discuss episode 9 “Are you an environmental, health and safety road warrior?” Key points 1) Get yourself a routine, 2) get yourself the right kind of luggage, laptop case, and you might want to consider getting yourself a great set of headphones. 3) good hotel that’s close to where you’ll be working and try to stay there routinely so that you can get to know the people that work there. 4) loyalty programs 5) technology – smartphone and compliance management software systems such as Affytrac, 6) know the local environmental, health and safety community 7) staying connected back at home 8) go with the flow and relax.
Main topic for today: “Industrial hygiene in the pharmaceutical industry.”
Industrial hygiene in the pharmaceutical industry
Mention journal article. Dr. Joe Nieusma, Senior Occupational Toxicologist with Affygility Solutions, and Angela Coler of Affygility Solutions. Article is titled “Strategies for preventing occupational exposure to potent compounds” 2010 edition of Toxicology Mechanisms and Methods. In that article, Joe, Angela, and I discuss that since the 1970’s, occupational toxicologists, industrial hygiene professionals and other occupational health professionals in the pharmaceutical industry have recognized that occupational exposure to active pharmaceutical ingredients can cause unintended health effects in workers handling these substances. In our Advanced Topics in Potent Compound Safety webinar, Dr. Nieusma, always discusses that chemical compounds that are routinely handled in the pharmaceutical industry are unique from other chemicals in that these compounds are designed to have an effect on the human body. In an occupational setting, if an employee provides a pathway of exposure to a potent compound, there is a high probability that the compound is going to elicit the designed response. Industrial hygiene professionals and other occupational health professionals in the industry have responded to this hazard recognition by employing strategies for the risk evaluation and control of potent active pharmaceutical ingredients, otherwise known by the term “potent compounds.” In this paper we provide an overview of the necessary strategies for preventing occupational exposure to potent compounds and the components of a good potent compound safety program. If you’re an industrial hygiene professional you should get a copy of this paper.
The strategies for preventing occupational exposure to potent compounds are very similar to any other industrial hygiene process, and consist of anticipating and evaluating the hazards of potent compounds; determining which of those process activities pose the highest risks; evaluating those risks, and finally, controlling potential exposures primarily through engineering devices.
Discuss stages of development.
Don’t go into the definition of a potent compound, refer to article
Discuss Strategy Component Evaluating the Hazards of Existing and New Compounds
Discuss scientific literature search and just getting started in developing a potent compound safety program. The industrial hygiene professional needs to gain an understanding of the potential hazards of all of the company’s products.
Discuss challenge of finding information for new compounds. Primary focus is to identify sufficient information to allow preliminary classification of the potent compound into a control banding strategy. Don’t go into details about control banding in the pharmaceutical industry. Suggest our potent compound safety webinars on this topic or do some research on this subject. Mention common modification to the classification scheme is typically in the number of classification bands. The number of bands that a company chooses to employ depends on the range of pharmaceutical products in the company’s portfolio and the number of control options that the company has implemented. Affygility Solutions uses a 5 band scheme.
When you or your occupational toxicologist are searching for potential literature sources of information, these can originate from both inside a company and from published scientific literature.
Discuss primary articles or internal data.
Marketed chemical entities, the literature can possibly provide all the necessary data to complete a potent compound safety classification. Discuss professional judgement. Caution that work should be done by an occupational toxicologist with the training and experience to be able to look at the data. My advice – use a professional, Ph.D degree, occupational toxicologists with the training and experience in the pharmaceutical industry. If you’re new to the pharmaceutical industry, you may want to get yourself a good book on understanding how therapeutics work. A book that I often recommend is the Pharmacological Basis of Therapeutics by Goodman and Gilman.
Don’t go into the details of how you evaluate active pharmaceutical ingredients, refer to the journal article or to our Advanced Topics in Potent Compound Safety webinar.
Discuss strategy component: Conduct Risk Assessments on All Potential Exposure Scenarios
After you have an understanding of the potential hazards of the compound has and a preliminary occupational exposure limit has been calculated, the occupational toxicologist or industrial hygienist should perform a detailed risk assessment. Risk assessments are often an overlooked, but extremely important, component of a potent compound safety program. These risk assessments will contain a number of risk factors that will define the probability of exposure. These risk factors include how the active pharmaceutical ingredient is handled, the physical form, the quantity, the frequency and duration of exposure, and several other factors. Ideally, a well developed potent compound safety program will have completed detailed risk assessments on every step of the process. Discuss non-routine activities, such as emergency repair activities, spill situations, or equipment failure. In order to appropriately conduct a risk assessment, a number of departments will need to be involved. These departments can include: industrial hygiene, occupational toxicology, occupational health, and operations. Industrial hygiene professionals likely will take the lead on risk assessments.
Discuss Strategy Component 3: Evaluate Potential Exposures
Discuss risk-based monitoring strategy. Exposure assessment strategies such as those used for other industrial hygiene purposes are fine. But, briefly, exposure assessments are utilized to identify the need for engineering controls or in the case where engineering controls alone are not adequate to control occupational exposure, if personal protective equipment is required as an additional means of protection. Data from an exposure assessment or industrial hygiene results will determine the level of containment achieved and if other means of controlling exposure are required.
When conducting air monitoring for potent compounds, it is frequently the case that air sampling and analytical methods will not be available and will need to be developed by specialty industrial hygiene analytical laboratories. We go into a lot more detail on this subject in our webinars, so I won’t discuss it here. However, during the interval of method development for a potent compound, the integrity of the containment strategy can be tested. Common practice in the pharmaceutical industry to use either lactose or naproxen sodium to perform surrogate monitoring on the equipment prior to inclusion of the more potent compounds. This practice is typically called performing containment validation studies. Discuss that the industrial hygiene professionals at Affygility Solutions have significant experience in performing these types of studies.
Data is used to determine how the containment strategy will perform when the potent compound is actually introduced.
Review exposure assessment results, the industrial hygienist will need to evaluate the data and compare to the field notes to determine the activities and operations that contribute to increased exposures. Exposure assessments are a critical tool for performance verification of engineering controls.
Discuss poor operator practices. Training is critical. Consistent techniques, attention to detail, and proper use of the available engineering controls is critical in preventing occupational exposure to potent compounds.
Discuss Implement Risk Management and Control Measures
The primary focus of a comprehensive potent compound safety program is to prevent occupational exposures through effective process containment. When handling highly potent compounds, containment must be provided during all steps in the process. Typical containment devices include the use of downflow booths during weighing or dispensing activities, the use of high containment or split butterfly valves during product transfer between containers, local exhaust ventilation near dust generating activates, closed systems, vacuum transfers, and the use of isolators to enclose the process. Engineering controls need to be a workable design, ergonomically correct, and user friendly or they will quickly be relegated to the backroom by operators. Minimize operator interaction in a process, and the exposure potential will also be minimized.
Discuss administrative controls such as time limits for operator exposures, gender restrictions, biomonitoring protocols, and process changes to eliminate operator variability. As anyone in the field of industrial hygiene knows, the use of personal protective equipment should only be used as a tertiary means of exposure control.
Strategies for preventing occupational exposures to potent compounds require that all elements be considered. Failure to control exposures to potent compounds can result in costly program missteps, delayed production schedules, or potentially hazardous exposures to workers. A comprehensive potent compound safety program will have contributions from occupational toxicology, industrial hygiene, safety, engineering, and operations. The bottom line is employee safety and increased productivity.
O.k. That does it for the discussion on “Industrial hygiene in the pharmaceutical industry. If you have any comments or feedback – I loved to hear it. You can call our listener voicemail feedback line at 206-984-3214 and leave an audio comment. You can also stalk us on twitter at twitter.com/Affygility, or follow us on Facebook by just searching for Affygility Solutions and giving us a “Like. You can also email us your comments at podcast at Affygility.com.
Discuss upcoming events.
National Association for Environmental Management MIS Conference to be held on March 2nd and 3rd in San Antonio, Texas. I will be attending this event and showing off our new mobile EHS app
March 11th through 15th, I will be attending South by Southwest Interactive in Austin, Texas.
Discuss April webinars. In addition to our very popular webinar on Advanced Topics in Potent Compound Safety, we also have a webinar on Dermal Exposure to Active Pharmaceutical Ingredients, Global Harmonization System, Hazardous Wastes for Hospitals, Clinics, and Medical Laboratories. I would suggest that you go to Affygility.com and look at our full schedule.
Discuss Young Guns of Environmental, Health and Safety. Need several volunteer guests. If you’re between the age of 25 to 34, and work in the environmental, health and safety field please send me an email if you’re interested in participating. My email address is email@example.com
Remind to submit your questions to our voicemail feedback line at 206-984-3214 and stalk us on twitter at twitter.com/Affygility, on Facebook by searching for Affygility Solutions and giving us a “Like”, and finally on LinkedIn by searching for Affygility Solutions.