Manufacturing and quality assurance
Pharmaceutical manufacturing environments are highly regulated and frequently monitored. The challenge for manufacturers is to be effective, avoid waste and minimize risk while providing proof of an encompassing quality program. Analytical equipment plays an important role as the results and values produced are used as proof tools verifying that systems are operating within designed specifications.
Instrumental solutions therefore need to be effective and repeatable, with minimal or no operator interpretation. PANalytical offers non-destructive turnkey solutions, based on X-ray powder diffraction (XRPD), X-ray fluorescence (XRF) and near-infrared (NIR) technologies, designed to enhance drug manufacturing and support the most demanding of quality environments.
Typical applications include:
- API polymorph confirmation and quantification
- Drug PAT crystallization control
- Raw material identification and control
- Elemental impurities by XRF (ready for USP <232> Limits and <233> Procedures as permitted by XRF <735>)
- Metal catalyst or metal reagent residue analysis by XRF (ready for Ph. Eur. general chapter 5.20)
- Excipient elemental limit testing
Enhancing productivity and reducing waste
PANaltyical’s energy dispersive (ED) XRF spectrometers, Epsilon 3XLE and Epsilon 1 Pharma, offer quick and reliable elemental analysis designed to provide rapid answers confirming manufacturing controls are functioning properly and provide proof of final product purity. Examples of use include residual catalyst and heavy metal (elemental impurity) testing.
X-ray powder diffractometers such as the CubiX³ Pharma and X’Pert³ Powder are designed for automated crystalline API control and laboratory flexibility respectively. Both provide automated polymorph control with advanced search-match identification algorithms and automated report generation.