Services
Consultancy and Project Management
Pharmaceutical manufacturing requires an environment that is designed to meet cGMP standards. Product quality assurance and contamination control are key requirements and Pharmatech Solutions brings the skill-set and engineering experience to ensure that your process, utilities and manufacturing space is designed to meet the rigorous demands of an FDA-licensed facility. This is a key requirement for facilities that are designed for drug substance (API), drug product (fill/finish) manufacturing and medical devices manufacturing.
Our project managers have joined teams seamlessly and successfully implemented projects, pipeline programs and other transformational initiatives within pharmaceutical, biotech, and medical devices/diagnostics companies.
We offer services from factory design to commissioning, qualification and validation of the facility as well as providing equipment.
Pharmatech Solutions is present in Europe, North Africa and the Middle East with offices in Germany, Algeria and the UAE.
Equipment installation
Our qualified service team has been fully trained at our suppliers’ facilities and are fully experienced to install complete injectable lines with isolators and freeze dryers. This includes placing the equipment in the room, connecting all ducts and cables, performing leak tests and calibration.
Naturally we also act as project managers at site so that our suppliers and our customers are aligned on the progress of the project. Also we assist by performing media fill, cycle development as well as all validation activities at site.
Solid dosage equipment such as coating machines, granulation lines, tablet presses, blending equipment, milling equipment and effervescent tube filling machines are also installed by us.
Our strength is to be able to provide a professional service locally. Our fully trained technicians are available within 24 hours.
Commissioning and validation
We assist our suppliers with commissioning and starting up equipment at site.
Our technicians are present at our suppliers’ sites two to three weeks prior to the FAT and typically participate in dismantling the equipment after FAT. This helps planning a smooth installation and start up at the customers’ site.
Our technicians are also trained on the stand-alone equipment to independently perform installation, commissioning and validation.
We also support our suppliers and customers to assist in qualification and validation of their equipment at site. Tests are usually performed using qualification and validation documents provided by our suppliers.
Spares and format parts
There are many reasons for using spare parts from original manufacturers. Parts have been designed for a precise purpose, often not fully understood by companies that copy. Tolerances between parts is key to ensuring optimal efficiency of the equipment and smooth operation for decades. All our suppliers ensure parts are available for at least 10 years and are GMP/FDA compliant. Material certificates are provided for product contact parts as well as calibration certificates for most electronic parts.
The highly reliable in house designed parts for machines, products and packaging are developed to specific customer requirements and each format part is thoroughly tested in our suppliers’ format centres before delivery. The format parts are always designed for quick change over and have been engineered to perform well at high speed.
Our technicians can also assist our customers to install their new spare and format parts.