As the potency and toxicity of APIs increases, so do the requirements for the equipment used in pharmaceutical manufacturing. In particular, the systems used to capture and dispose of dusts need an upgrade to ensure that personnel aren’t exposed to hazardous materials and to protect against cross-contamination of products. With HPAPIs, there’s simply no room for error.
This is why many pharmaceutical manufacturers are transitioning from standard dust collector systems to dust containment systems, which use cyclone pre-separation in conjunction with one or more HEPA filters to capture dust and guarantee safe disposal of the collected material. Let’s explore some major advantages of dust containment systems for solid dose manufacturing.
Worker protection and compliance with OSHA standards
The number one reason to use a dust containment system is to protect your workers against workplace hazards. This keeps your workforce safe as well as keeping you on your OSHA inspector’s good side. (Respiratory protection and occupational exposure to hazardous chemicals in laboratories were two of the most common OSHA violations for pharmaceutical and medicine manufacturing last year.)
Keep in mind that according to OSHA’s three lines of defense scheme, engineering controls are the most effective, and thus the highest priority, when it comes to protecting workers.
For APIs that fall into occupational exposure band (OEB) 1 or 2, which are considered nontoxic or practically nontoxic, personal protective equipment (PPE) and in-house procedural controls are often sufficient. APIs in OEB 3 are considered slightly toxic — this is the level where we start to see interest in dust containment systems. However, when you get to OEB 4 (toxic) and higher, the occupational exposure limit (OEL) becomes miniscule. At these levels, a dust containment system is the only way to make sure no hazardous dust escapes into the environment.
Maximum protection against cross-contamination
Keeping your workers safe may be goal #1, but protecting your products from cross-contamination is a close second. Cross-contamination can lead to product and monetary losses, more frequent visits from auditors and inspectors, a damaged reputation, and — in the worst-case scenario — a suspension of your manufacturing license.
Standard self-cleaning dust collection systems use compressed air to clean the HEPA filter while the filter is still online. However, compressed air cleaning is your worst enemy because it presents two risks:
- The material inside the hose or dust collector can move back into the vacuum point creating cross-contamination issues.
- The increasing pressure inside the filter can generate dust dispersion if the system leaks. Eliminating compressed air cleaning ensures you always have negative pressure inside the dust collector, which prevents dust dispersion.
Dust containment systems use a cyclone pre-separator before the HEPA filter. This filterless technology is up to 99% efficient at capturing dust, leaving only the remaining 1% to reach the HEPA filter. In this way, the HEPA filter serves as an insurance policy, rather than as the main point of protection. Because of this design, no compressed air filter cleaning is necessary and the HEPA filter lasts much longer, which means you need to change the filter much less often.
Easy product reconciliation
Product reconciliation (i.e., accounting for all of the materials used in a production run and measuring that against the final yield) is one of the most important methods of quality assurance.
Dust containment systems can help quality assurance personnel calculate yield and reconcile loss. Since the cyclone captures 99% of the dust and routes it to an easily removable plastic bag, practically no dust accumulates on the filter. This makes it very easy to determine exactly where the raw materials go during the production process.
Very little maintenance required
In a system that relies solely on HEPA filtration, the main maintenance task is changing the filter when it becomes clogged. Since a cyclone pre-separator doesn’t have a filter, a dust containment unit is practically maintenance-free. Dust collected inside the cyclone is removed by use of a butterfly valve and single use bag. Dust is discharged into the bag which is removed and replaced applying a bag-in/bag-out procedure. Not only that, but the system can be washed in place (WIP) to deactivate the dust on inside surfaces following use.
If you use highly toxic APIs in your manufacturing process, it’s time to consider moving to a dust containment system. View our brochure to learn more about these systems and how they can protect your people and your products, while also improving your process.