The pharmaceutical coating process often requires the use of hazardous or harmful materials. The equipment available at Thomas Processing makes it simpler and safer to control the factors involved in using these materials. Let’s discuss the factors involved and the importance of features such as Wash-in-Place and ancillary equipment.
The coating process manufacturers use in pharmaceutical tablets often involves the presence of dangerous chemicals and materials. These materials present an inherent danger, but they can be met with preparation and vigilance. Dealing with the manufacture or use of hazardous materials means you must take the necessary precautions to protect your personnel, the environment, and the product itself from harm or damage.
To reduce expanding costs and prevent time lost, it is crucial to understand the level of protection or containment required in your process. The opportunities and applications for containment are expanding throughout the pharmaceutical industry. Thomas understands these dangers, and we offer the equipment you need to have proper protections in place. Allow us to help you consider the inherent risks in the coating solution process and how we can adapt to them for the better.
Safety Precautions for Hazardous Materials
There is more to the process of coating tablets than just determining the most efficient and reliable ways to apply film to a tablet. One must also consider the intended purpose of their coating equipment, the personal protective equipment (PPE) involved, and containment necessary for the proper handling of hazardous materials.
What Is Containment?
“If an overall manufacturing facility consists of three components – pharmaceutical material, personnel, and the environment surrounding them – containment is the isolation of the first of these components from the other two.” – ISPE
We are seeing an increase in containment applications across the pharmaceutical industry. Products such as cytotoxics, anti-cancer drugs, hormones, and steroids all present a possible hazard to your personnel and environment. Due to their potency and possible toxicity, these types of materials are regulated for their exposure levels or OEL.
Chemical and Hazardous Materials Safety Terms
There are vital acronyms and terms to know when building your strategy for containment and considering the health and safety of your employees.
OEL stands for Occupational Exposure Limit. OEL is the airborne concentration of a compound to which nearly all workers can repeatedly be exposed eight hours a day, 40 hours a week, without adverse effects.
ADE is the Accepted Daily Exposure = OEL*10 (8 hour time weighted average) based on a low clinical dose
OEB is the Occupational Exposure Band and system to classify chemicals based on the severity of the hazard. It bands certain chemicals into groups based on OELs (if known) or their inherent toxicity or potency, if no data exists, to establish safe handling guidelines.
TWA is the Time Weighted Average. These chemicals are subject to exposure limits and include materials that have carcinogenic or mutagenic characteristics or other products that pose significant risk if inhaled. Most products we deal with have exposure limits calculated over an eight hour period.
STEL is the Short Term Exposure Limit or the exposure level over a specific task time
SMEPAC is the Standardised Measurement of Equipment Particulate Airborne Concentration: a test procedure adopted by the industry to test the integrity of the containment level.
There are many things everyone involved in the film coating process needs to know to ensure safe practices and operation without interruption. Luckily, Thomas Processing is here to help your team and facility be prepared for these factors and how to address them.
Get Your Facts Straight
This is a step-by-step analysis of the entire process so you can produce a detailed list of all the tasks involved.
Set Your Goals
Set Containment Performance Targets (CPT).
Build Your List of Tools
Specify and select your containment equipment based on the above list of tasks and CPT.
Trust But Verify
Verify the containment performance at either or both of the FAT and SAT stages (SMEPAC test) to confirm the effectiveness of the design CPT
Examine and Reassess
Assess the occupational exposure to your workers and environment during actual operation. Take this information and make the required changes.
All of these steps and the information they provide are vital to the containment process and keeping the operations in your facility safe for everyone involved. All of these terms and steps might sound like a lot, but the good news is that Thomas Processing is here to make it easier with the right tools and our modern equipment.
Thomas Processing provides a wide range of equipment and service features that offer benefits to every type of customer we partner with for tablet coating operations. For example, the Flex 05, Flex 100, Flex 200, Flex 500, and Flex 1000 all come with multiple containment benefits for your operations including:
- Inflatable seals
- Easy access design
- Fully welded cabinet
- Rounded corners/no beading
- Sealed exhaust plenum removable with drum
- Exposed drum rollers
- Simple, tool-less and rapid drum removal procedures
We also offer Wash-in-Place (WIP) systems with features including:
- WIP nozzles strategically located inside the coater
- Zone valves with 3-4 zones
- WIP recipes that are product dependent
- Cleaning procedures that are chemistry, time, and temperature dependent
- Multiple WIP configurations available
To learn more about how our systems aid your processes in containment while minimizing the risk to your employees and the chance of cross-contamination, contact Thomas Processing today.