Webinar: How Using the Right PAPR Can Improve Safety & Productivity in Pharmaceutical API Production & OSD Work Streams

In this webinar, ILC Dover team members discuss the safety, productivity, and process improvements that can be achieved by implementing correct standard operating procedures and leveraging Powered Air-Purifying Respirator (PAPR) solutions over other respiratory options.

Through a live demonstration of the Sentinel XT™ Clear PAPR System, the webinar reviews how this revolutionary unit works and how operators experience the solution in terms of comfort and productivity. We also share the latest organic vapor/acid gas cartridge data, demonstrating strong results for increased wearer safety and protection.

WATCH: How Using the Right PAPR Can Improve Safety & Productivity in Pharmaceutical API Production & OSD Work Streams



[Doug Durney] 0:05
Welcome to the webinar today where we’re going to discuss how using the right PPE can improve safety and productivity in pharmaceutical API production workstreams. I’m Doug Durney, the Product Line Manager for PPE at ILC Dover. I’ve been involved in the design, sales, and marketing of engineered solutions and protective equipment with ILC Dover for over 30 years. Daniel Jameson will be joining me.

[Daniel Jameson] 0:41
And I’m Daniel Jameson, Director of Business Development at ILC Dover, bringing 12 years of safety experience in manufacturing and the last four as a respiratory specialist.

[Doug Durney] 0:54
So let’s hop right into it. Today, we’re going to look at the hierarchy of controls, the use of containment and PPE in pharmaceutical workflow streams. We’re going to review our Sentinel Clear PAPR and discuss an upcoming product launch in Europe.

I’m sure you’re all familiar with this chart relative to the hierarchy of controls. Today, we’re going to discuss the use of engineering controls, which can help isolate people from the hazard, as well as personal protective equipment to protect employees when other controls are not available. ILC Dover pioneered flexible containment solutions for use in pharmaceutical applications, and we offer our Sentinel XT PAPR specifically designed to support life science applications.

I’d like to start by reviewing this chart here on OSD workflow covering granulation, tableting, and coating. Your process may look like this or it may look slightly different. We typically work with our customers by outlining their process and then helping offer solutions for the various unit operations. In some cases where containment solutions are not available, or even where they are, customers opt for the addition of PPE as well, often a PAPR. As you can see, the use of PPE is prevalent in weigh-in/dispense operations, blending, anytime open-air sampling is involved, tablet press operations, and sometimes final packaging. In addition, equipment cleaning and suite cleaning can also require the use of a PAPR or other PPE.

For chemical synthesis, a combination of containment solutions and PPE can also help protect workers. For API production, sampling is an area where they are prevalent, reactor charging, dryer unloading, milling, and sieving can also be appropriate applications for PPE.

From an engineering containment perspective, some available solutions include our DoverPac product for large-scale powder filling, emptying, and sampling during charging and offloading. Our EZ BioPac is also a solution in the bioindustry for powder containment and transfer to address media and buffer powders.

We offer a range of isolator solutions as well, including both passive and active configurations. Shown here is a version to support aseptic manufacturing and another design supporting the production of antibody drug conjugates, really bridging the gap between the biopharma sector and small molecule production.

Let’s take a quick look now at the respirators. If we look at the various types of NIOSH-approved air-purifying respirators, starting at the left, we see a traditional filtering facepiece. That’s followed by an elastomeric half-mask. Both of these require fit testing and have an APF of 10. Proceeding to the right, we have an elastomeric full-face respirator, which offers an APF of 50. All of these first three respirators require annual fit testing and require the operator to be clean-shaven since they are negative pressure designs. They inherently impose a physiological stress on the operator if used for long periods of time.

The PAPR solutions on the right-hand side of the chart include a loose-fitting design that carries an APF of 25, which is two and a half times the protection offered by the half-mask. The full-hood design offers an APF of up to 1000 with the appropriate simulated workplace protection factor data. Neither of these designs require fit testing, and their positive pressure reduces the physiological burden on the wearer. They also typically allow operators to have facial hair.

Now, Daniel will review our Sentinel XT PAPR.

Daniel Jameson 5:37
Thank you, Doug. Let’s now introduce you to our next-generation PAPR, the Sentinel XT Clear PAPR system, offering a truly panoramic field of view. Shown here, you can see the unique clear hood, which provides a panoramic field of view, distinguishing it from other PAPRs. Sentinel Clear will provide greater comfort and safety with better worker identification.

Sentinel XT has five key areas which separate it from other hooded PAPRs: namely high standard airflow, expansive field of view, ultra-long battery life, high reliability for a lower cost of ownership, and an ergonomic and comfortable design. With the Sentinel Clear, air enters from the back of the hood, and the Sentinel XT blower delivers a standard airflow of 8.3 CFM, significantly greater than the NIOSH requirement of 6 CFM. This airflow provides the wearer with an improved worker environment and a feeling of fresh air, which results in greater productivity. The design features a rear airflow plenum that delivers filtered air over the head and down over the face to wash away CO2, providing a comfortable feeling for the wearer.

The most distinguishing feature of the Sentinel XT Clear is the expansive 320-degree field of view. This allows the wearer to simply glance left or right and see the entire suite. The hood also includes a clear top section to enhance upward visibility. This full range of vision helps reduce feelings of claustrophobia and increases operator safety. As suites become smaller and more crowded, these benefits become even more significant for the operator and the facility.

We were just recently at a facility where this point was driven home about API production suites becoming crowded. With the full field of view, you can really make sure that your operators are staying safe.

Daniel Jameson 8:04
That’s true. That has been a big key point for a lot of users. Another standard feature of the clear hood involves its air-supported design. Once the inner bib is tucked into the suit, the hood inflates naturally, eliminating the need for an uncomfortable headband or ratcheted adjustments. This eliminates worker fatigue associated with constrictive headgear, provides more comfort for the operator, and increases overall productivity.

To ensure the system can be used for long shift operations, the Sentinel XT comes with a 12-hour lithium polymer battery. This eliminates the need for frequent battery changes and increases productivity. In addition, it comes with an easy-to-read battery life indicator, with each LED light indicating approximately three hours of blower life. Lastly, the batteries are serialized and barcoded, allowing for tracking and maintenance logging for greater accountability.

Doug Durney 9:12
So we have a question, which is how does the hood fare with potential snags on equipment in these crowded spaces?

Daniel Jameson 9:16
I’m going to skip back a couple of slides. Thank you for the question. The hood is obviously greater in size than traditional hoods, and we have found that on some cleaning operations, it may be necessary to have a smaller hood, which we offer, a more conformal one. But in the majority of manufacturing suites, operators are finding that it’s just much more flexible and gives them a better field of view. The top of this hood is actually clear as well, providing increased upward visibility. So bottom line, we really have not found it to be an issue other than in some cleaning operations.

Doug Durney 10:17
To ensure the system can be used for long shift operations, the Sentinel XT leads the market across all dimensions with its robust blower and ultra-long-life brushless motor design. With more than 10 years of in-field use, the system has proven to be very reliable. It includes a unique secondary impact-resistant chamber, the gray cover you see over the unit here in the photo. This product protects the internal air-moving unit in the event of inadvertent drops or bumps in the production area. Sentinel XT can be worn using either a quick-lock belt with a contoured lumbar plate or an ergonomic back harness. This provides a choice for operators depending on their usage scenario. Both configurations are fully submersible to facilitate cleaning, and having a lighter-weight blower helps improve comfort during operation.

Doug Durney 11:31
We have another question. What is the APF for this hood?

Daniel Jameson 11:37
The APF for the Sentinel Clear hood shown here is 1000. At ILC, we perform a lot of these protection factor tests. We run it through a whole series of operations and motions, and also a Los Alamos panel as far as the participants in that study. So it is an APF of 1000. Typically, the test data averages around 50,000, but obviously, we can only claim a thousand based on OSHA.

Doug Durney 12:10
Thank you again for that question. I think you’re answering those, Doug. I’m actually not seeing the questions pop up.

Daniel Jameson 12:12
Got it. The product comes in a non-incendive design to support use in hazardous atmospheres. It is Factory Mutual certified for use in Class 1 Div 2 locations. To distinguish it from the standard gray design, we changed the color to blue and included a secure battery latch, which assures that the battery pack cannot come out without the use of a tool. This feature is required by Factory Mutual. You can use a small screwdriver or pen to remove the battery pack, and it pops out as normal.

Doug Durney 13:27
In summary, the Sentinel XT Clear system offers many benefits for the operator and the company, all of which are focused on increasing safety, comfort, and productivity.

Daniel Jameson 13:41
We have a question here regarding whether the blower is submersible along with the belt. The blower is not completely submersible; it is sealed, but we recommend using decon wipes and not fully submersing it. Both the quick-lock belt and the back harness are fully submersible; they are heat-sealed configurations and all polymeric materials. The blower itself, however, should not be fully submerged.

Doug Durney 14:22
Let’s take a quick look at a demonstration of the product with a very short video, about two minutes and 30 seconds.

The robust XT blower system provides 8+ CFM airflow for increased protection. An integrated 12-hour lithium polymer battery supports a wide range of applications. The system is NIOSH approved and highly versatile with HEPA, OB, HG, HE, and multi-gas filter options. Sentinel XT is available in back harness and quick-lock configurations, supporting a wide range of user needs and preferences.

Let’s watch how quick and easy it is to install the quick-lock belt and back harness. Attach the rear hood clips to the back harness, install two HEPA filters into the blower unit, and install the blower plug. Turn on the blower and check the airflow with the supply flow meter. Turn off the blower and attach the breathing tube onto the hood and then onto the blower. Slide on the back harness, pull the Sentinel XT hood over your head, tuck the inner hood into your suit all the way around your neck, zip up your suit, secure the front bottom, and attach the bib’s front securing device. Finally, center the hood.

Doug Durney 17:14
For more information, visit our website.

Daniel Jameson 17:20
Moving on, we’ve recently done some testing on supplemental chemicals above and beyond the NIOSH chemicals required. Here are breakthrough curves for ethyl acetate and ethanol. These are based on multiple tests conducted by third-party labs. This information is useful for estimating changeout schedules based on monitored concentration.

We’ve done it for additional chemicals like acetone, chloroform, methanol, methylene chloride, and more. We continue to expand this list, and we have also tested parasitic acid, acetic acid, and hydrogen peroxide mixtures, simulating spore cleanse. We can provide actual breakthrough data on those concentrations as well.

We are getting ready to launch in Europe with a TH3 certification per EN 12941. The initial offering will be HEPA filtration only, with carbon filters coming soon. The initial offering will not have ATEX certification, but that is being pursued. The non-incendive version in the U.S. and Asia is available today and is Factory Mutual approved for Class 1 Div 2 certification.

Daniel Jameson 19:49
We are happy to conduct a product demonstration, either virtually or on-site. Reach out to your account manager or me to schedule a time to present to your team.

Doug Durney 20:07
At this point, I’ll open it up for any additional questions.

I believe I’ve answered all the questions. We’ve covered the APF and noise levels. Any other questions?

A question on the recommended changeout time of the HEPA-only filters. Daniel, do you want to take this one?

Daniel Jameson 21:13
Sure, Doug. Changeout times vary depending on the facility and contaminants. We typically ask about the chemicals used, contaminants, industrial hygiene, and air quality sampling in the facility. We can turn this information over to our engineers to get a recommended changeout schedule based on contaminants. More often than not, it’s for particulates in the area.

Doug Durney 22:04 – Right, and it depends on the application. It could be monthly, six months, or even up to a year, but most times we see significantly less than a year. The filters have passed NIOSH silica dust testing, where they are put in a snowstorm and must pass for four hours without reducing the flow below 170 CFM for NIOSH. They perform very well in these tests.

Another question: Could we go over the circumstances where a PAPR would be used instead of or as well as a high-spec primary containment?

Great question. Let’s take OSD. For excipients API blending, if there is contained addition to the blender, a containment solution may be adequate. For open-air additions, a PAPR or other respiratory protection may be recommended. We have flexible enclosures where customers use both containment and PAPRs. Difficult-to-contain unit operations are where PAPRs are chosen. Industrial hygienists often recommend both for extra security or conservative safety.

Daniel Jameson 25:26
Another benefit of PAPRs over elastomeric face masks is eliminating fit testing and allowing for facial hair, reducing costs and improving safety.

Doug Durney 26:17
I think that covers the questions. If we receive any others, we will provide written responses. We are happy to do personalized demonstrations of the product, either virtually or on-site. Looking forward to helping you solve containment and personal protective equipment needs. Thank you very much for your time. Have a great day.

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