Quality

Inspection
425e | C01 Page 1 of 5
Prepared: DH | 11.10.2006

Tested: RM | 17.08.2010

Version 3.0

Quality Inspection | Version 3.0 1|5

General information

Client:

BioSealer® type:

Serial no:

Production date:

Client order no:

SSS AG project no.:

Sartorius Stedim Switzerland AG | Reed Electronics

Manufacturer:

Technician

Name:

Signature:

Date:

Quality Inspection | Version 3.0 2|5

1. Installation Qualification
1.1 Criteria for acceptance

– Unit must be in operational condition with all parts and manuals.

– Unit is operated with 230 VAC/50 Hz.

Pos Description Fill in

Pos. 1 Part number: Internal product order no

Sartorius Stedim Switzerland AG | REED
Pos. 2 Manufacturer: N /A
Electronics
Pos. 3 Supplier: N /A Sartorius Stedim Switzerland AG

Pos. 4 Description: N /A BioSealer® sterile tube sealer

Pos. 5 Hardware version: Printed on bottom

Pos. 6 Serial number: See manufacturer plate (behind)

Pos. 7 Firmware Version BioSealer®: Only for manufacturer use

Pos. 8 BioSealer® type: See data plate at front

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1.2 Equipment list

Pos Item Version Confirm with

yes or no

Pos. 9 2 Ceramic heater plates type 0 1 Enclosed Yes No

Pos. 10 Manual Enclosed Yes No

Pos. 11 Certificate of Compliance 425.S12 Enclosed Yes No

Pos. 12 Reed temperature control certificate Enclosed Yes No

Specification sheet 425.F04, only necessary by custom sealing
Pos. 13 Enclosed Yes No
parameter
Pos. 14 Torx key for ceramic heating elements N /A Enclosed Yes No

Pos. 15 Power cable 90VAC-250VAC according to country export Enclosed Yes No

Pos. 16 Manufacturer and data plate N /A Installed Yes No

Pos. 17 Danger notice sticker N /A Installed Yes No

Pos. 18 One tube of ordered type and wall-thickness are available. Tube Type and Size: Yes No
(this tube is used for the OQ too).

Correct tubing distance plate installed according to

Pos. 19 Colour: Yes No
Order no.: or 3.2 mm = green
2.4 mm = black
BioSealer® Specification Sheet 425.F04. 1.6 mm = black
Correct sealing parameters uploaded according to Parameter (standard): P
Pos. 20
Order no.: or If custom parameters:

BioSealer® Specification Sheet 425.F04. Pre-sealing temperature [°C]

Pre-sealing time [s]

Sealing temperature [°C]

Sealing time [s]

Temperature encrease [°C/s]

Unlock temperature [°C]

Comment

Inspection of this device was done by:

Date: Name: Signature:

Quality Inspection | Version 3.0 4|5

2. Operational Qualification
2.1 Criteria for acceptance

– Unit must operate automatically without the need for operator intervention.
– Three test seals of one ordered hose type and size type must be visually acceptable with no holes, bubbles or tears.
Tube type (brand) and inner|outer diameter as per Pos. 19 (page 4).
– Counter function is working. (See the counter status before and after the OQ).

Pos. 1 Counter status before the OQ: , and after OQ:

Seal no: Successfully passed - visual check Counter functions work correctly

Pos. 2 1 Yes No Yes No

Pos. 3 2 Yes No Yes No

Pos. 4 3 Yes No Yes No

Confirm with
yes or no

Pos. 5 Unit operates automatically without operator intervention Yes No

2.2 Release Check

Confirm with
yes or no

Pos. 6 Visual check on external damage (buckles, scratches, clefts) Yes No

Pos. 7 Check for loose items Yes No

Pos. 8 All parts are repacked Yes No

Pos. 9 QC conformity sticker is mounted in front of device (initials from Technical Engineer and date). Yes No

Comment

Inspection of this device was done by:

Date: Name: Signature:

This document is reviewed and released by QA:

Date: Name: Signature:

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