CleanroomProcesses

17.04.2023
GMP-Reinigungsanlagen
Steelco GmbH

Exceed industry standards
Washing/Drying machines available as single door or pass-through double version, with automatic motorized opening in vertical (either up or downward) or horizontal sliding doors. All machines feature large glass sliding doors to reduce size and assure easily and safety access.

√ Highest cleaning performance
√ Protection of processed items
√ Low power and consumption
√ Drying efficiency system
√ Repeatable and validatable process
√ Globally available components and technical support
 

Steelco has an in-depth understanding of the particular critical cleaning, disinfection and drying requirements of equipment and components used in pharmaceutical production.

Inspection, testing, documentation and training
We believe on the importance to show and to demonstrate that all the steps of the manufacturing processes, starting from the specifications and the component selection up to the assembly and factory testing are made in accordance with the customer specifications and performance requirements. Steelco can furthermore demonstrate and document that our quality control program strictly follows the Good Engineering Practice. Steelco follows the ISPE's GAMP guidelines to respect the project execution and the supplying of the documentation to support the customer's qualifications.

Comprehensive validation support documentation
» To ensure compliance with specifications and documentation is maintained, in-process checking is performed during the manufacturing process.
» A FAT (Factory Acceptance Test) is made on each unit and a complete set of documentation is supplied to the customer together with installation, user and instruction manual when the machine is delivered.
» On request Pre-Qualification of the system can be supplied: this will carry out the same test procedures as defined in the IQ-OQ protocols to be later performed on site as part of the validation process. This procedure will help the start up of the machine pointing out any minor issue with the equipment and the documentation and precede the site acceptance testing which will be performed later on.

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