Following on from our previous two blogs which highlighted the importance of particle size analysis in the pharmaceutical industry and the value the Mastersizer 3000 brings to drug development, in this final blog we will turn our sights to why the Mastersizer 3000 is considered an “essential instrument in a quality control laboratory” and within manufacturing in the pharmaceutical industry.
When used on a daily basis in production-critical environments, it’s essential that the data you use to control your process is robust and reliable, optimizing process efficiency and increasing output. Within Quality Control (QC), it is recognized that there are increasing demands on the time of users, making it imperative that instruments are easy to use and intuitive. Here, the feedback from our customers on Select Science is loud and clear, with results described as being “of high quality and reproducible”, the instrument as “very simple and robust” and “very easy to use”. The drive for increased data integrity and 21CFR11 compliance adds further complications for those working within the pharmaceutical industry, and we have a range of support materials to help in this area. The Mastersizer 3000 helps address these challenges in a number of ways:
- Data integrity and 21 CFR Part 11 compliance: range of enhancements in data security enable you to meet regulatory requirements and ensure data traceability
- Reduced downtime: Reliable, stress-free operation helps decrease the Total Cost of Ownership (TCO) with simple, low-cost routine maintenance keeping processes running at optimal levels
- Confidence in data: reliable, repeatable, reproducible data delivers confidence in results and improvements in both process consistency and product quality
- Expanded analytical functionality: Sensitivity to detect small changes in production batches and/or larger contaminant or material means that process or product problems can be rapidly identified and rectified
To find out more about how the Mastersizer 3000 and Malvern Panalytical’s other instrumentation can help solve your pharmaceutical challenges, take a look at our pharmaceutical industry page.
- Brochure – Mastersizer 3000
- Focus on Pharma: Particle sizing – Managing Method Development
- Focus on Pharma: Particle sizing – Advance your Analysis
- Focus on Pharma – Elemental Analysis: Simplify your workflow
- Particle Size and 21CFR Part 11 – Data Integrity with you Mastersizer 3000
- 21CFR Part 11 – Mastersizer 3000 – A How-To Guide
- Whitepaper – Answering the challenge of setting effective particle size specifications during pharmaceutical product development
- Malvern Panalytical Drug Development Technologies (from Pharmaceutical Technology)