A spray dryer used in a chemical plant may look similar to what you see in a pharmaceutical plant producing Active Pharmaceutical Ingredients (API) but the project execution and documentation are completely different. The figure below illustrates the different project phases that equipment for pharmaceutical production has to include:
Quality by Design
Pharmaceutical industries have to follow Guidelines and Directives given by FDA (US), EMA (EU) and ICH whenever materials for man are produced. One requisite for any such process is that equipment is qualified to be fit for the purpose. And equally important, that this is carefully documented.
User Requirements Specification (URS) may be an elaborative document prepared by the user and based on years of R&D work with a specific drug. Or GEA Niro may assist with a more general list of requirements that secures that the spray dryer can be qualified for production of an API.
The joint tasks may require man months to accomplish when the spray dryer is to be specialised for a finished drug. However, if one of GEA Niro's standard GMP Spray Dryers (type QSD) can do the job only a few modifications to existing documentation may be needed. During Design Qualification (DQ) the final check is made that the equipment actually will be able to produce the product quality specified.
Before leaving the workshops all components have to pass the Factory Acceptance Tests (FAT) that were defined in connection with DQ. The FAT documentation not only includes material certificates and instrument manufactures’ calibration certificates. Copies of welders’ certificates are included, welding seems are inspected, and surface finish measured – just to mention a few. And very important, all activities are carefully documented to fulfil pharmaceutical Qualify Assurance demands.
After mechanical erection and electrical and pneumatic cabling on site it is time for the Site Acceptance Test (SAT). GEA Niro can prepare protocols with testing procedures and reporting sheets for SAT and the following Installation Qualification (IQ) and Operational Qualification (OQ). GEA Niro also offers to assist Customers in performing these activities on site.
During SAT, IQ and OQ the Customer’s personal will normally be trained so they can perform the Performance Qualification (PQ) with the pharmaceutical product by themselves.
Different product lines to fulfil different requirements
Please find more details on the GEA Niro product lines for the pharmaceutical industries: