2 - Safety
Operating Company
Tecan Vacuum Separator (Te-VacS™) Operating Manual, 391236, en, V4.0
13 / 54
•
Observe all safety instructions of the instrument the Te-VacS is used on.
2.3 Operating Company
The operating company must ensure that the Te-VacS and in particular the safety
features, function properly and that all the personnel in contact with the instrument
are adequately trained.
Responsi-
bilities
•
Method and process validation.
•
Defining the processes in compliance with the Standard Operating Procedures.
•
Ensuring that installation and operational qualifications (IQ OQs) have been
completed.
•
Ensuring that all personnel in contact with the Te-VacS are adequately trained.
•
Ensuring the availability of appropriate protective clothing and equipment.
•
Ensuring the maintenance and safe operation of the Te-VacS.
•
Requiring adherence to laboratory safety regulations and directives.
2.4 User Qualification
The laboratory personnel must be fully qualified and trained to operate the
Te-VacS. The work described in this Operating Manual must only be performed by
authorized personnel 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,
•
and have read and understood the instructions in the Operating Manual.
Tecan recommends that the operator attends an operator training course. Please
ask the Tecan Customer Service about available courses. Refer to section
.
2.4.1 Operator
The operator (lab technician) works for the operating company.
Required Skills
•
No specific application or system knowledge
•
Command of local languages
•
Command of English is preferable
The operator has application software access rights allowing him to run methods
and perform system care.
2.4.2 Key Operator
The key operator (application specialist) supports the operating company or works
for the same company.
Required Skills
•
Extensive application knowledge
