Equipment Installation, Commissioning, Validation and Training

We were commissioned by a contract pharmaceutical manufacturer to increase the throughput of a coating facility.

Project Scope:
Install a coating machine - a GLATT "Coater GC 1000" - from another leading pharmaceutical manufacturers site. Perform associated commissioning, validation and training activities.

Scope of Services:

Audit of the machine before moving
• Parameters and performance
• Risk assessments

Commissioning and start up
• Cabling, HVAC balancing, SAT
• Qualification - from DQ to PQ
• Cycle development and optimisation

Cleaning and product validation
Operator training
• Using knowledge from work at the previous site and qualification activities at the new site
• Product validation runs were also performed by the client's own operators

• 9 weeks from commissioning to production.
• Product validation performed without non conformity.
• Operators fully trained and able to produce validatable batches without supervision.