Operating Company; User Qualification; Operator - Lonza PyroTec PRO Hardware User Manual

3 Operating Company

The operating company must ensure that the PyroTec™ PRO and the safety features func-
tion properly and that all the personnel in contact with the instrument are adequately
trained.
Responsibilities
• Method and process validation.
Defining the processes in compliance with the Standard Operating Procedures.
•
• Ensuring that installation and operational qualifications (IQ OQs) have been com-
pleted.
• Ensuring that all personnel in contact with the PyroTec™ PRO are adequately trained.
Ensuring the availability of appropriate protective clothing and equipment.
•
• Ensuring the maintenance and safe operation of the PyroTec™ PRO.
• Requiring adherence to laboratory safety regulations and directives.

3.1 User Qualification

The laboratory personnel must be fully qualified and trained to operate the PyroTec™
PRO. The work described in this User's Manual must only be performed by authorized per-
sonnel with the qualifications prescribed below.
Laboratory personnel must:
• Have suitable technical training,
Be familiar with the laboratory safety regulations and directives,
•
Be familiar with the instructions for the safety elements of the instrument,
•
• Use protective clothing and equipment,
Be familiar with and adhere to good laboratory practices,
•
Have read and understood the instructions in the User's Manual.
•
Lonza recommends that the operator attend an operator-training course including routine
use and end-user maintenance training. Please ensure training requirements are stated
clearly on a completed pre-installation checklist.

3.1.1 Operator

The operator (lab technician) works for the operating company.
Required Skills
Command of local languages
•
• Command of English is preferable
The operator has application software access rights allowing him/her to run methods and
perform system care.
PyroTec™ PRO Hardw are User's Manual, V1.2
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