Testing Facilities
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For continuous process improvement and validation
As an essential element of Dec's dedication to quality, customers are provided with the ability to test their products, or a suitable test product, using our in-house test plants, pre-purchase.
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Tests are prepared and carried out by Dec's specialists, and of course, the customer is welcome to join us on site to observe the process.
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From powder handling including powder characterization to SMEPAC testing and particle size analyses, Dec has a full range of facilities and equipment as well as skilled technicians to support your needs.
SMEPAC - Standardized Measurement of Equipment Particulate Airborne Concentration
To demonstrate equipment containment performance, Dec provides its own testing cabin to carry out tests in line with the ISPE's SMEPAC guidelines using micronized lactose or naproxen sodium as surrogate materials and all necessary equipment to complete containment verification testing including SKC Sidekick pumps and filters for air sampling.
The modular positive pressurized test enclosure includes ULPA filtration with material and personal airlocks. The tests are carried out by Dec's specialized personnel according pre-approved surrogate testing protocols, supervised and managed by an independent certified industrial hygienist (CIH) who is experienced in potent compound handling.
The protocol identifies the key points where a break could occur i.e. airlock, endless liner, outlet of exhaust filter etc. and static samplers are installed adjacent to the these potential break points and on the operator.
All samples taken including surface swab testing prior to and after the containment verification are sent to a NVLAP (National Voluntary Laboratory Accreditation Program) laboratory who has developed an analytical testing method using a high performance liquid chromatography (HPLC) method.
According to the guidelines, three consecutive runs are performed (time permitting) with a collection of typically 20 samples and a detection limit of 2 ng/filter sample.
Within 2-3 weeks, a final Industrial Hygiene Monitoring Report will be prepared which summarizes the analytical testing results.
Dec's capacities for product trials include the following equipment and possibilities:
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Powder transfer up to 100 m distance and 30 m height, from mg to tons
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FIBC discharge and filling, drum and bag handling up to OEL < 1 µg /m3
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Mixing up to 100 l
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Micronizing from MC DecJet® 30 to MC DecJet® 300 up to OEB 5 containment with particle size analyses
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Milling and sieving
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Various crushing and delumping systems
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Sampling
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Liquids handling
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Microdosing from 1 mg to 100 gr
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Powder sterilization
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SMEPAC testing booth
