The pharmaceutical sector plays a pivotal role in ensuring the health and well-being of individuals worldwide. In fact, guaranteeing top quality products, free from any contamination, is vital to avoid any complications like adverse or side effects for patients. That’s why the industry is regulated by strict rules of hygiene, sanitation, and cleaning procedures (like the GMP – good manufacturing practices). Using the correct and dedicated equipment is therefore the only choice. Of course, this includes the handling and disposal of dust.
WHAT ARE THE SOURCES OF DUST HAZARDS IN THE PHARMACEUTICAL INDUSTRY?
The truth is that most of the production processing in the pharma industry generates some sort of powder dispersion or dust hazard.
The highest number of accidents and injuries in the pharmaceutical industry are caused by the manual handling of fragile materials. As a clear consequence, accidental spills are a recurring event.
However, production processes like weighing and dispensing cause real dust hazards; these processes entail the transferring of powder from a bulk container into smaller units. Keeping these processes in a closed and automatic system like a pneumatic conveyor is essential to guarantee operators’ safety and top-quality products.
Also, during the weighing process, powder puffs and airborne dust can easily be generated. The use of a portable dust collector can effectively prevent the dispersion of dust into the environment.
Granulators convert powders into granules for easier processing, while tableting machines form tablets from granules with precise dosages. These two phases of the production line generate large amounts of non-toxic (OEB 1 – OE2), medium TOXIC (OEB3) and toxic materials/ active ingredients (OEB4 – OEB5). A specific industrial vacuum cleaner (especially if combined with a pre-separator), can guarantee the safety of the handling and cleaning processes. Solutions like the PHARMA 20.18, PHARMA 40.40, PHARMA 40DC or SEP.DC-001/SEP.DC-002, specifically designed to manage these powders with the best results of filter and containment, guarantee the total safety of the operators and the cleanliness of the production line.
Tablet presses generate powder and dust during the compression of granulated materials into tablet form. As the machine exerts pressure to compact the granules into a solid tablet, fine particles may be released into the surrounding environment. This dust can consist of the pharmaceutical ingredients, excipients, and, in some cases, minute fragments of the tablet itself. To mitigate potential risks associated with airborne particles, pharmaceutical manufacturers implement stringent containment measures and employ specialized equipment such as dust extraction systems, like portable dust collectors, to maintain a controlled and clean production environment. Along with portable dust collectors, industrial vacuums like the DG models help retain the tablet by means of vacuum pumps and powder suction. Finally, pneumatic conveyors load the empty capsules and powders.
The same thing happens with blister machines; when tablets are compressed and ejected into blister cavities, the potential release of fine particles occurs. Making sure to control any spread of dust during the loading of tablets (by using, for example, a pneumatic conveyor), or vacuuming powder dispersed during the packaging phase, can be easily done using a Delfin Industrial solution like the DG70. For the removal of blister welding residues and trimming, a pharmaceutical industry can rely on the AS line or a central vacuum unit with a pre-separator.
Finally, coating machines generate powder and dust during the loading and handling of tablets, essential to create the coating film. To mitigate potential issues related to product contamination or operator exposure, making sure to use a closed and safe system like a pneumatic conveyor is essential.
Basically, containment is the keyword of the pharmaceutical industry, especially when dealing with toxic dust.
WHAT IS CONTAINMENT IN THE PHARMACEUTICAL INDUSTRY?
In the pharmaceutical industry, containment is a series of measures taken to limit the spread of a given substance into the environment, thus protecting both operators’ health and productivity. The level of hazard is usually represented by the so-called “containment pyramid”, whose goal is to identify the correct protection equipment for the efficiency and effectiveness of the plant.
The containment pyramid is based on the OEB (Occupational Exposure Band, whose level range from 1 up to 5) and OEL values (Occupational Exposure Limit). Together, they identify the level of toxicity of a powder.
- Very low toxicity
- Low toxicity
- Medium toxicity
- High toxicity
- Very high toxicity
So, the equipment used for the containment of powders depends on the toxicity of the handled ingredients, which are split into two main categories: API, Active Pharmaceutical Ingredients, and HPAPI, Highly Potent Active Pharmaceutical Ingredients. In API are included very low, low and medium toxic powders, which can be managed with lower risks. HPAPI are highly and very highly toxic ingredients, which therefore require the highest level of safety. That’s why the containment of these powders is a primary concern and need, and that’s why Delfin Industrial offers specific API/HPAPI containment solutions. The operator and the environment must never come into contact with these powders. Solutions like the PHARMA 40.40DC, equipped with a bag collecting system and manufactured in AISI 316 stainless steel (parts in contact with the powder), guarantee the maximum powders filtration (complying with OEB4-OEB5 levels), thus ensuring total operator’s protection. A cyclonic pre-separator (the real star of the product), traps up to 98% of powders (tested with placebo powder).
A cyclonic pre-separator like SEP.DC-001 or SEP.DC-002, manufactured in polished AISI 316 stainless steel, with cyclone dust separation maximum efficiency up to 98%, contribute to the safe powder collection thanks to the crimpable containment bags (SEP.DC-001) and the container in AISI 316 stainless steel.
THE ADVANTAGES OF USING DELFIN INDUSTRIAL VACUUMS AND A PHARMA DUST CONTAINMENT SYSTEM
To conclude, when it comes to collecting powders and dusts, there are some main features and rules in the pharmaceutical industry that need to be guaranteed:
– operators’ safety
– the safe containment of toxic active ingredients (API & HPAPI)
– the quality of the finished product, by avoiding any cross-contamination among different production cycles
– the hygiene of the working environment.
Using Delfin Industrial solutions for the pharmaceutical industry will provide tremendous benefits:
- INCREASED SAFETY FOR OPERATORS
- HIGH QUALITY OF FINISHED PRODUCTS
- IMPROVED LEVELS OF PRODUCTION EFFICIENCY AND COST REDUCTION
- REGULATORY COMPLIANCE
In fact, Delfin Industrial solutions follow pharma OEB best practice and respect the fundamental GMP manufacturing requirements. Like smooth surfaces and angles; the prevention of any dust accumulation by using only AISI 316 stainless steel material (for the parts in contact with the dust); and suitable material to prevent any operator’s injury or dust accumulation. Moreover, Delfin Industrial’s containment and filtration units can be installed in technical compartments. Also, on request, mirror polished AISI 316 stainless steel can be provided for the parts in contact with powders.
If you want to find out more about the possibility of the Pharma and Dust Containment line, contact us today! Our team of experts will get in touch to show you the several benefits and advantages of using quality-guaranteed products!