By MEDELPHARM S.A.S
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MEDELPHARM: STYL’One GMP Production Accessories
MEDELPHARM’s fully instrumented STYL’One Evo is a highly versatile single-punch tableting press for Research & Development, scale-up and production support. This all-purpose tableting instrument supports a broad range of needs from fast API characterization and single layer to multi-layer formulation development.
The STYL’One Evo compaction simulator can be configured with a wide range of options including software modules and accessories that precisely tailor its capabilities to specific applications and needs.
GMP Production module
As international specialists in innovative technologies and services for powder processing, MEDELPHARM is dedicated to helping its customers optimize their practice by tailoring their tableting instruments to precise and individual needs.
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
For customers who need to comply with strict Good Manufacturing Practice (GMP) guidelines, MEDELPHARM offer a range of accessories and software options that allow the STYL’One Evo platform to meet GMP production requirements.
STYL’One Evo can be upgraded to full GMP production standards by adding a dedicated software and a sorting chute.
Other accessories for GMP Production environments include a series of add-on features and capabilities that meet FDA, EMA and other regulatory guidelines, particularly in the areas of quality validation.
These accessories include:
- GMP software with CFR part 11 compliance
- Automatic weight regulation
- Good/bad tablet selection
- Linear ejection system
- Micro-dispensing unit for external lubrication
- Vacuum and negative pressure for operator safety in low OEL environments
- FAT/SAT and IQ/OQ validation
MEDELPHARM can also provide advanced operator training to help companies and their employees comply with GMP guidelines.
Founded in 1985 in Lyon, France, MEDELPHARM has more than 35 years of experience in the tableting sector. Among other initiatives, the precision engineering company designs and manufactures research & development compaction simulators, and provides innovative solutions for powder analysis and formulation support.
Staffed by a dedicated team of scientists and technicians, the MEDELPHARM Science Lab performs trials with predictive results and supports its customers with formulation and powder characterization challenges. In addition, MEDELPHARM Distribution also represents a range of solutions in powder processing, from R&D to production.
For more information, visit: www.medelpharm.com.
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