Pharmaceuticals are a necessity for the numerous medical conditions out there, and as time goes on, the active ingredients used to make them have gotten more hazardous, meaning the importance of containing dust from the manufacturing process has also increased. Dust containment systems for solid dose manufacturing are a must to contain the spread of the dust that comes off the machines during manufacturing. This protects the workers and environment around the manufacturing labs, as well as prevents cross-contamination.

Dust containment systems often contain multiple parts. Firstly, there is some form of containment unit at the entrance to any lab that manufactures solid dose pharmaceuticals to ensure a safe entry and exit point. Here, PPE can be put on or taken off, without the risk of spreading pharmaceutical dust. Next is the fan system with a cyclonic pre-separator that creates a negative pressure area in a room, so that the only way for dust to get out of the room is through the fan’s filtration system. Lastly, there is a HEPA filtration system to ensure that if any dust does make it through the fan’s cyclonic pre-separator system, the HEPA filter will capture it, ensuring zero dust leaves the room.

Protection Against Cross-Contamination

Cross-contamination in solid dose pharmaceuticals is a major concern. Dust from the manufacturing of one drug, getting into another drug can drastically change its effects on a person, making a relatively safe drug into one that is dangerous, or completely useless. A facility that has cross-contamination will have to issue product recalls, costing millions of dollars, as well as increasing the frequency of auditors and inspectors, eventually leading to the loss of their manufacturing license.

With a robust dust containment system in place though, solid dose manufacturing will no longer have to worry about cross-contamination when procedures are properly followed, and the system is installed correctly. Previous systems often included self-cleaning fans, however the vacuum point of air compression cleaning can create cross-contamination issues, so more modern cyclonic pre-separator fan systems with HEPA filters are now preferred. Dust containment must be a priority to prevent cross-contamination, including full room negative pressure fans, as well as an environmental containment unit at any entrance to allow for safe PPE dressing and undressing.

Worker Protections and OSHA Standards Compliance

There are many classifications of active pharmaceutical ingredients (API’s) used for solid dose manufacturing, and dust containment is a way to prevent the dangerous API’s from causing health issues inside, and outside of a manufacturing lab. API’s in the occupational exposure band (OED) 1 or 2 are considered non-toxic, or limited toxicity so often only requires proper procedural PPE and controls, but when manufacturing starts using OED 3 or 4 category, dust containment becomes a must. OHSA inspections are something regularly done in a manufacturing setting where there are dangerous ingredients, and OSHA standards must be met or exceeded for continued manufacturing to be permitted. Dust containment systems ensure that no dangerous ingredients get out of working labs, whether that is into other areas of the building, or the outside environment.

Product Reconciliation

In an ideal world, all the ingredients used in solid dose manufacturing would go into the end product, however, this is not an ideal world, and some of the product is lost as dust and other waste products during the manufacturing process. Dust containment systems not only help protect the outside environment and people from toxic API, but it also allows for easy capture of ingredient dust so that the manufacturer can use the dust captured in reconciliation calculations. This way they know exactly how much ingredients are being lost to dust, in order to determine whether more efficient means of manufacturing are needed, and as part of quality assurance calculations.

Little Maintenance Required

A great aspect of dust containment systems that don’t wholly rely on HEPA filters, is the fact that cyclonic pre-separation technology required little cleaning and requires fewer HEPA filter changes. Combined with a robust entrance containment unit, there is little maintenance required to ensure a safe containment area for solid dose manufacturing

Full Dust Containment System

Full dust containment systems are a must for most solid dose manufacturing to ensure product safety, employee safety, and environmental safety. Combining pre-separation cyclonic fans featuring HEPA filtration, with environmental containment units at entrances ensures total safety and containment while following proper procedures.