There is a growing trend for pharmaceutical ingredients, particularly Active Pharmaceutical Ingredients (API’s), which consist of smaller molecules to provide faster reactions and greater potency. Solvents are often used in the processing phases. Whilst providing significant benefits in terms of drug delivery and performance, it creates a number of challenges for pharma manufacturers and their production processes.
The API’s create very fine dusts and often high solvent concentrations during the product handling and manufacturing processes. The finer the dust, the greater explosive potential due to increased surface area and greater concentration. There are certain values which need to be determined (Kst, Pmax, MIE) so the correct explosion protection and explosion venting measures can be specified as part of the dust extraction system. Vigilance is required to ensure the correct safety devices are specified for the dust collector and EX-rated items of supply. Compliance with ATEX and OSHA regulations is key. Yearly checking and maintenance of equipment by qualified persons is mandatory.
The fine dusts also pose the greatest risk to the worker’s health, with harmful particles being retained in the lungs. An effective filtration is required combined with containment solutions to ensure the dust doesn’t escape during normal operation as well as during routine maintenance.
Malaysia
