Validation

 

It is a task to classify and diagnose the performance and function of Biological safety cabinet and

various Clean benches by IQ and OQ through professional inspection equipment to

judge compliance with GMP facility safety standards.

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Biological Safety Cabinets, Clean Bench, Autoclave, Freezer, Refrigerator,
Incubator, Dry Oven and Centrifuge equipment can be verified.

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> Installation Qualification (IQ)

Verify and document on-site that the machine, equipment or

system has been installed to established standards. ​

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> Operational Qualification (OQ)

Verify and document that the machine, equipment or

system operates as intended within the expected operating range. ​

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> Performance Qualification (PQ)

Verify and document whether the machine, equipment or

system can manufacture products to established quality standards.

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In addition to reports for GMP certification, Soft Validation, which is carried out separately

from the Alpha line, will be provided free of charge when the filter is replaced.
(This is a report on the activity history for self-management purposes)

※ Simple validation is free when you change the filter.
(Task report for equipment management purpose)

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※ If you receive VALIDATION SERVICE from Alpha Line, we will attach

Inspection Certificate and management sticker.