Biopharma EHS Podcast Episode #10.mp3

 

BioPharma EH&S Podcast Episode No. 10

Note: This is the abbreviated script of the podcast, for the more detailed version go to http://potentcompoundsafety.com/?p=642

Cover what we talked about last time in episode number 9

Then I will cover our main topic for today, which is “Industrial hygiene in the pharmaceutical industry.”

Discuss upcoming events and happenings of importance to environmental, health and safety professionals in the BioPharma Industry.

Discussed the topic of “Are you an environmental, health and safety road warrior?”  Get into our main topic for today which is “Industrial hygiene in the pharmaceutical industry.”

What I’m going to talk about here is based off of a journal article written by myself, Dr. Joe Nieusma, Senior Occupational Toxicologist with Affygility Solutions, and Angela Coler of Affygility Solutions.  This article is titled “Strategies for preventing occupational exposure to potent compounds” and was published in a 2010 edition of Toxicology Mechanisms and Methods.  In that article, Joe, Angela, and I discuss that since the 1970’s, occupational toxicologists, industrial hygienists 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 hygienists 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.”

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.  These strategies should be applied at all stages of pharmaceutical product development including discovery, pre-formulation, initial test batches, pilot plant, scale-up, and production.  These strategies can be applied to initial discovery of a potent compound by an innovator company or to the development of a product coming off patent by a generic pharmaceutical company.

Don't go into the definition of a potent compound, refer to article

So, let’s now talk about our first strategy component, the first component is Evaluating the Hazards of Existing and New Compounds

Prior to the introduction of any new APIs into the workplace, a thorough scientific literature search on the specific or similar compounds should be conducted.  If your company is just getting started in developing a potent compound safety program, a thorough literature search should be performed on pharmaceutical products already in the company’s portfolio – either in development or already on the market.  The industrial hygiene professional needs to gain an understanding of the potential hazards of all of the company’s products. While retrieving literature and understanding the hazards may seem like a fairly simple task, for new compounds early in the development process it is often challenging to find information that is relevant to an occupational exposure scenario.  However, the primary focus should be to identify sufficient information to allow preliminary classification of the potent compound into a control banding strategy.  Much has been written about control banding in the pharmaceutical industry, so I won’t go into those details today, but would suggest you either attend one of our webinars on this topic or do some research on this subject.  I will however mention that one of the most common modification to the classification scheme is typically in the number of classification bands individual companies utilize for their products.  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. As an example, Affygility Solutions use 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.  Primary articles, can come from high quality databases from the National Library of Medicine can provide published resources on numerous chemical substances. However, for discovery compounds, the internal toxicology studies will provide the most useful information.  If the chemical entity has been on the market for a significant period of time, the literature can possibly provide all the necessary data to complete a potent compound safety classification.  Once the data has been assembled, professional judgment must be exercised to evaluate the data and determine the critical toxicological endpoints.  

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. Also, in addition to manufacturing processes, risk assessments should also be conducted for 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.

Strategy Component 3:  Evaluate Potential Exposures

 

After you have completed risk assessments, a risk-based monitoring strategy will need to be developed.  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 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.  It is a very 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.  Affygility Solutions has significant experience in performing these types of studies, so if you need more information please don't hesitate to contact us.  The data from these evaluations can then be used to determine how the containment strategy will perform when the potent compound is actually introduced.

After you receive the exposure assessment results, the industrial hygienist will need to carefully 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.  Operator effects are numerous.  Even the most sophisticated engineering controls can be ineffective due to poor operator technique or failure to follow established procedures. It’s been my experience that a single instance of inappropriately using a compressed air hose to remove spilled dry API from the top of a container can result in an 8-hour time weighted average exposure that is 400% higher than other who did not use a compressed air hose.  Training is critical to decrease or eliminate variability in operator technique.  Consistent techniques, attention to detail, and proper use of the available engineering controls is critical in preventing occupational exposure to potent compounds

Implement Risk Management and Control Measures

 

The primary focus of a comprehensive potent compound 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.  The operator interface is one main aspect that is controllable.  Minimize operator interaction in a process, and the exposure potential will also be minimized.

In addition to engineering controls, other risk management strategies may need to be utilized.  These can include administrative controls such as compound-specific hazard communication training and product-specific medical surveillance.  However, these aspects cannot be considered as a substitute for the previously mentioned engineering controls.  Other examples of administrative controls include time limits for operator exposures, gender restrictions, biomonitoring protocols, and process changes to eliminate operator variability.  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 program will have contributions from occupational toxicology, industrial hygiene, safety, engineering, and operations.  The bottom line is employee safety and increased productivity.

O.k.  The 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.

Alright, let’s now talk about some great upcoming events.

The first event is the 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, so if you would like to meet up with me, please feel free to call the listener voicemail feedback line and let me know that you’re going to be there.

The second event is the Society of Toxicology meeting on March 6th through 10th in Washington, DC.  Dr. Joe Nieusma, Senior Toxicologist with Affygility Solutions will be attending this event, so if you would like to meet with Joe and discuss potent compound safety, so let me know.

Next, on March 11th through 15th, I will be attending South by Southwest Interactive in Austin, Texas.  I’ve been looking at the schedule of sessions and events that will be happening at South by Southwest and it is amazing.  This event is going to be “off the chain”. If you don’t know what that means “Google it” and find out.

I should also mention, that in April, we have several new webinars starting and you should look at our schedule at Affygility.com.  These webinars have been very well attended and we have received a lot of positive feedback on them.  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.  Again, if any of that interests you, I would suggest that you go to Affygility.com and look at our full schedule.

Finally, I’m starting to prepare for a podcast on the Young Guns of Environmental, Health and Safety, and I 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 [e-mail]

O.k.  That does it for this week’s show.  Remember 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 onLinkedIn by searching for Affygility Solutions.