Validation Services
(Spanish and French files are being updated; sorry for the inconvenience; please access English information below)

Factory Validation Services available for Atlas Vac Tray Sealers & Blister Sealers Installation

Qualification (IQ): All data pertaining to the identification of the equipment (model number, serial number, power rating, control systems I.D. numbers, etc.) is recorded to ensure full traceability. Utilities verification is conducted to confirm power and air supplies are adequate. PLC addresses are verified for correct wiring. Additional information such as purchase order verification, equipment manual familiarization, standard operating procedures training, and preventive maintenance review may also be included.

Operation Qualification (OQ): Temperature and pressure values are certified where any calibration has expired. All standard and optional control functions are verified. E-stops and interlocks are checked for functionality. All machine functions are tested and all devices challenged to ensure that design standards have been achieved. Equipment is usually challenged for deviation, loss or interruption of power and air pressure. Data report functions are verified where equipped. Controls communication with the client LAN, when this option is equipped, is also verified in support of 21 CFR Part 11.

Process Validation (PV): Atlas Vac will provide the client with tray sealer validation, of specific package designs, at selected sealer parameters (temperature, pressure, dwell) to meet a previously specified client sealed package testing method. Development of the appropriate parameter operational ranges is critical to quality as well as productivity. Tool and seal design analysis is available as well on existing units.

Atlas Vac Machine offers Validation Services designed to efficiently augment our customer's staff in launching tray sealers into production promptly while ensuring that regulatory documentation requirements are executed.

Custom Validation Services, tailored to the specific needs of the customer or product, are available. Re-validation of sealers undergoing upgrades or re-tooling, whether Atlas Vac or other brand "x" equipment, is available.

Need help?
Contact Sales
Contact Customer Service.

 

Return to Atlas Vac Home Page (English)

Return to Alas Vac Home Page (Espanol)

Return to Atlas Vac Home Page (Francais)