Manufacturing Process Support
We offer quality assurance programs, cleanliness validation and failure analysis for the pharmaceutical manufacturing process. Ensuring product and material quality consistency, performance and cleanliness and identifying the causes of failures quickly and accurately is vital to any pharmaceutical or pharmaceutical packaging manufacturer.
Surface technologies play an important role in accelerating the development of pharmaceutical products and in the optimisation of manufacturing processes so that ‘pipeline’ products reach the market place quickly. Critical interactions continually take place between surfaces of product, plant and packaging throughout the manufacturing process and indeed the entire pharmaceutical product life cycle.
Cleanliness Validation
Achieving and maintaining cleanliness throughout the manufacturing process is critical to the pharmaceutical industry. Contaminants can be introduced at each phase of manufacture (such as as milling, turning, blasting, polishing, lapping, deburring, laser treatment, printing and surface modification such as plasma deposition). Understanding and monitoring the effectiveness of each cleaning stage, by surface analysis, residue analysis and particulate assessment, means that not only can we help manufacturers to confirm the final cleanliness validation of the process and products but can also monitor each step to determine where contamination is introduced should problems occur.
Ceram provides a complete validation service for the pharmaceutical manufacturer, VALIDATA, to determine the effectiveness of the cleaning process and environment on an ongoing basis.
Quality Assurance
We work with pharmaceutical manufacturers to develop and provide quality assurance programs to ensure product and material quality consistency and performance to criteria. We offer batch-to-batch conformity testing, from which results can be utilised for regulatory authorities and internal QA/QC protocols.
Examples of some of the projects we’ve worked on:
- Surface analysis of drug powders demonstrating variable solubility
- An XPS investigation of active loading on drug powders for dry powder inhalers (DPIs)
- Investigation of antibody (IgG) immobilisation on polyethylene and polystyrene beads by XPS and ToFSIMS
- Investigation of the efficacy of cleaning procedures to remove drug and other residues from used YTZ beads
- Surface analysis of micro-milling beads after conditioning
- Investigation of tablet hydration using 3D non-contact profiling
