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API AND HPAPI DUST CONTAINMENT SYSTEMS
25/01/2022
Research to develop increasingly effective treatments for serious diseases has led to the creation of drugs with increasingly potent active ingredients, called (HPAPI - Highly Potent Active Pharmaceutical Ingredients). When working with these active ingredients, the manufacturer's first concern must be to ensure maximum protection from exposure for employees, as these substances pose a real risk to their health. In addition to the use of appropriate PPE, it is essential to identify and implement an effective dust control strategy, taking into account a number of production-specific factors, such as the degree of danger of the substance, the quantity of the substance handled, the level of dustiness and the duration of operations.
Dust control can then provide protection to the working environment and consequently to the operators themselves. OEL (Occupational Exposure Limit) thresholds have been defined for operators' safety, indicating maximum levels of product concentration per cubic meter. If the values remain below these thresholds, the operator is not at risk even if exposed for 8 hours a day. The toxicity level of the principle, called OEB (Occupational Exposure Band), is defined on the basis of the hazard to health and the above-mentioned characteristics.
Delfin has developed specific solutions for the pharmaceutical industry, that is the Dust Containment range, which complies with GMP guidelines and is equipped with safety systems designed to allow work with highly potent active ingredients in total safety.
The main machines involved in the production of tablets, capsules, and powdered pharmaceutical products require continuous suction and dust containment to different extents. Nevertheless, the aim is always to maintain product quality at its highest level and to preserve the health of the operators. Compressors, Blister machines, Capsule fillers, Bassines, Granulators are perfect applications for high containment solutions.
THE DUST CONTAINMENT RANGE
Designed in collaboration with important machinery manufacturers in the pharmaceutical world, the new Dust Containment range stands out for its flexibility and compactness as well as the construction quality that has always distinguished Delfin products.Maximum safety for operators, also during maintenance, and full compliance with GMP and EHS standards.
SAFETY FOR THE OPERATORS
The products are equipped with safety systems that prevent any contact between the vacuumed pharmaceutical powder and the operators.
CONTAINMENT FOR PHARMACEUTICAL DUSTS
A cyclonic separator separates dust from air and collects it in the dust hopper. The efficiency level is up to 98% without filter intervention, thus reducing maintenance operations. Dust is then conveniently disposed of by means of the bagging system.
To filter the remaining dust, up to 3 additional levels of absolute filtration can be installed with the Bibo replacement system.
The same systems can be equipped with cyclone separators that guarantee filtration even with higher suction power up to 810m³/h.
The air at the extractor outlet is diffused through imperceptible slots at the back of the extractor, which do not allow the air to exceed 3m/s.
SAFE DUST COLLECTION AND DISPOSAL BY MEANS OF CONTAINMENT BAGS
The material is disposed of by adjustable containment bags that can be sealed by means of a crimping tool. This way, contact with dust is totally avoided.SAFETY AT EVERY STAGE OF MAINTENANCE
All product maintenance steps are designed to be carried out quickly and safely
REPLACEMENT OF FILTERS WITH BAG-IN BAG-OUT SYSTEM
H14 Absolute filters are replaced by means of a Bibo hermetic system that prevents any leakage, thus offering maximum protection to the operators carrying out the replacement. Therefore, the system allows to change the filter on-site with no need to move to a technical room.
WASH-IN-PLACE CLEANING SYSTEM
Units in contact with dust can be cleaned by submersion. With this process, dust attached to surfaces is deactivated. A filter allows excess air to escape by retaining any puffs of dust inside, while water is discharged from the butterfly valve installed on the hopper.FULL COMPLIANCE WITH GMP GUIDELINES
The products have been designed to fully comply with good manufacturing practice, facilitating cleaning and sanitisation.
SMOOTH SURFACES
Clean design with no dust accumulation points
TOP QUALITY CONSTRUCTION AND MATERIALS
All parts in contact with substances are made of polished AISI316 stainless steel (AISI316L optional), thereby guaranteeing ease of cleaning and maximum hygiene.All connections to pipes are Clamp type to ensure maximum tightness in every application.
SIMPLE MONITORING OF UNITS
The machines can be equipped with various systems for signaling the status of the machine, filters, and full container, to simplify monitoring and prevent possible problems.COMPACT AND FLEXIBLE UNITS FOR DUST CONTAINMENT
The real advantage of the new Containment range is that it provides compact, easy-to-move units as solutions to complex problems. The PHARMA40, the showpiece of the new range, can safely operate with dust up to OEB level 5 (OEB 4 during maintenance) simply by equipping the right dust separation system.
PHARMA 40
For powders up to OEB3 we have redesigned some of our best solutions to meet GMP and EHS standards. These solutions can also be equipped with absolute filtration and safe dust collection and disposal systems.
PHARMA 40 DUST CONTAINMENT
The PHARMA 40 in DUST CONTAINMENT configuration can work with OEB5 powders (OEB4 during maintenance) with airflow rates of up to 420m³/h.The same systems can be equipped with cyclone separators that guarantee filtration even with higher suction power up to 810m³/h.
The air at the extractor outlet is diffused through imperceptible slots at the back of the extractor, which do not allow the air to exceed 3m/s.
HOW TO CONFIGURE THE CONTAINMENT SYSTEM
The high flexibility of the new containment units allows different configurations of the system, either for direct connection to the process machinery or for use with a separate suction unit located in the technical compartment.Contact us and we will configure the most suitable dust containment solution for your needs.
