Sat Im
Sat Im
Sat Im
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:
HMA/QA/SAT001-00 Page 1
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
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CONTENT
Title Page
Table of Content
1.0 System Information
2.0 Document Details
3.0 Protocol Approval from Customer
4.0 Objective
5.0 Scope
6.0 Acceptance Criteria
7.0 Responsibilities
8.0 Checkpoints and Testing
List of Reference Documents
9.0 Installation Qualification
List of Reference Drawings
Bought Out Components
Dimension Measurements
Input Output Check (If applicable)
10.0 Operational Qualification
Cycle Operation (Running Trial)
Operation Sequence
11.0 SAT Report
12.0 SAT Report Approval
Abbreviations
HMA/QA/SAT001-00 Page 2
M/S: HMA MEDICAL
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Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
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1.0 SYSTEM INFORMATION
Shanghai Poyton
Production
Engineering
Quality Assurance
Administration
4.0 OBJECTIVE
HMA/QA/SAT001-00 Page 3
M/S: HMA MEDICAL
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Injection Moulding Plant Shanghai Poyton Industry
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To confirm, by physical inspection and testing, that the fabrication and assembly of the
equipment and any auxiliary support systems, conforms to the Design parameters according
to the Design Review.
5.0 SCOPE
Verify the FAT documents for the tests carried out at Shanghai Poyton for the equipment.
The tests shall be carried out at the customer’s place.
The verification of compliance to specifications - according to DR documents and to GMP
requirements, shall be done by:
Confirmation that all design documents, specifications and tests certificates are
accurate, approved and available.
Physical inspection of the electrical hardware.
Mechanical inspection of the construction of the equipment.
Functional testing (safety tests) of the equipment with printouts for tests that require
supporting documentation.
The design documents specifications and test certificates shall be accurate and
approved.
The electrical hardware shall comply with the approved design specifications.
The individual tests performed shall conform to the agreed acceptance criteria.
Compliance of deviation recorded during FAT and acceptance of deviation of SAT by QA.
7.0 RESPONSIBILITIES
Inspection
Customer or their authorised representatives are responsible for this SAT document.
All documents shall be checked and approved by Quality Assurance or their authorised
representatives.
Production personnel will perform this test.
HMA/QA/SAT001-00 Page 4
M/S: HMA MEDICAL
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Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
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Details of Documents
HMA/QA/SAT001-00 Page 5
M/S: HMA MEDICAL
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Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
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Conclusions
Performed by Checked by
Name
Signature
Date
HMA/QA/SAT001-00 Page 6
M/S: HMA MEDICAL
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Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
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9.1 Content
Description
Bought-out components
Dimensional report
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Co. Ltd.
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Objective To check reference drawings required for job against list mentioned below.
Material Approved drawings list submitted in the FAT/Final Documents.
Verification of FAT document with actual material.
The submitted documents shall be checked for correct Drawings No., Version
Method No., Date and Authorization details against the details submitted in the FAT
Test form by the vendor.
HMA/QA/SAT001-00 Page 8
M/S: HMA MEDICAL
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Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
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Conclusions
Performed by Checked by
Name
Signature
Date
HMA/QA/SAT001-00 Page 9
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
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TEST Job No.:
To prove that the Bought Out components used for construction of the
Objective
equipment are as per the approved specifications.
Material Bought Out components specification sheets.
Verification of documents submitted during FAT.
HMA/QA/SAT001-00 Page 10
M/S: HMA MEDICAL
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TEST Job No.:
1 O-ring φ82.5×3.55mm 2
3 O-ring φ48.7×3.55mm 1
7 O-ring φ67×3.55mm 2
9 O-ring φ33.5×3.55mm 1
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M/S: HMA MEDICAL
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Injection parts
4 O-ring φ48.7×3.55 4
5 O-ring φ25×3.55 2
7 O-ring φ118×3.55 4
8 O-ring PCB0A1250-NCR0 2
11 O-ring φ60×3.55 2
HMA/QA/SAT001-00 Page 12
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
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TEST Job No.:
HMA/QA/SAT001-00 Page 13
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:
HMA/QA/SAT001-00 Page 14
M/S: HMA MEDICAL
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Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
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TEST Job No.:
reversing valve
Electromagnetic
31 DG4V-3-3C-J-MUH5-60 DSG-01-3C12-D24-N1-50 4WE6L6X/SG24N9K4
reversing valve
Electromagnetic
32 DG4V-3-6C-J-MUH5-60 DSG-01-3C4-D24-N1-50 4WE6J6X/SG24N9K4
reversing valve
Electromagnetic
33 DG4V-3-7C-J-MUH5-60 DSG-01-3C9-D24-N1-50 4WE6M6X/SG24N9K4
reversing valve
Electro-hydraulic
34 DG5S4-042A-J-MUH5-60 DSHG-04-2B2-E-D24-N1-50 4WEH16D6X/6SG24N9K4
reversing valve
Electro-hydraulic DSHG-04-2B2B-ET-D24-N1-
35 DG5S4-042BL-J-MUH5-60 4WEH16EB6X/6SG24N9TK4
reversing valve 50-L
Electro-hydraulic
36 DG5S4-042C-MUH5-60 DSHG-04-3C2-E-D24-N1-50 4WEH16E6X/6SG24N9K4/B10
reversing valve
Electro-hydraulic
37 DG5S4-042C-MUH5-60 DSHG-04-3C2-E-D24-N1-50 4WEH16E6X/6SG24N9K4/B10P4.5
reversing valve
Electro-hydraulic DSHG-04-2B2B-ET-D24-N1-
38 DG5S4-042C-T-MUH5-60 4WEH16EB6X/6SG24N9TK4/B10
reversing valve 50-L
Electro-hydraulic
39 DG5S4-043C-T-MUH5-60 DSHG-04-3C12-ET-D24-N1-50 4EH16L6X/6SG24N9TK4
reversing valve
Electro-hydraulic
40 DG5S4-046AL-E-MUH5-60 DSHG-04-2B2-E-D24-N1-50-L 4WEH16Y316X/6SG24N9K4
reversing valve
Electro-hydraulic
41 DG5S4-046C-T-MUH5-60 DSHG-04-3C4-ET-D24-N1-50 4WEH16J6X/6SG24N9TK4
reversing valve
Electro-hydraulic
42 DG5S4-042B-T-MUH5-60 DSHG-04-2B2B-E-D24-N1-50 4WEH16EA6X/6SG24N9K4
reversing valve
Electro-hydraulic
43 DG5S4-0431C-T-MUH5-60 DSHG-04-3C10-ET-D24-N1-50 4WEH16U6X/6SG24N9TK4
reversing valve
Electro-hydraulic
44 DG5S4-H8-0A-MUH5-60 DSHG-06-2B3-E-D24-N1-51 4WEH22C6X/6SG24N9K4
reversing valve
Electro-hydraulic
45 DG5S4-H8-2C-MUH5-60 DSHG-06-3C2-E-D24-N1-51 4WEH22E6X/6SG24N9K4
reversing valve
Electro-hydraulic
46 DG5S4-H8-2C-T-MUH5-60 DSHG-06-3C2-ET-D24-N1-51 4WEH22E6X/6SG24N9TK4
reversing valve
Electro-hydraulic
47 DG5S4-H8-3C-T-MUH5-60 DSHG-06-3C12-ET-D24-N1-51 4WEH22L6X/6SG24N9TK4
reversing valve
Electro-hydraulic
48 DG5S4-H8-6AL-E-MUH5-60 DSHG-06-2B2-E-D24-N1-51-L 4WEH22Y316X/6SG24N9K4
reversing valve
Electro-hydraulic
49 DG5S4-H8-6C-T-MUH5-60 DSHG-06-3C4-ET-D24-N1-51 4WEH22J6X/SG24N9TK4
reversing valve
Electro-hydraulic
50 DG4V-3-2C-MUH5-60 DSG-01-3C2-D24-N1-50 4WE6E6X/EG24N9K4
reversing valve
Electromagnetic
51 DG4V-3-31C-MUH5-60 DSG-01-3C10-D24-N1-50 4WE6U6X/EG24N9K4
reversing valve
Electromagnetic
52 DG4V-3-2B-MUH5-60 DSG-01-2B2B-D24-N1-50 4WE6EA6X/EG24N9K4
reversing valve
HMA/QA/SAT001-00 Page 15
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:
Conclusions
Performed by Checked by
Name
Signature
Date
HMA/QA/SAT001-00 Page 16
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:
HMA/QA/SAT001-00 Page 17
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:
Conclusions
Performed by Checked by
Name
Signature
Date
HMA/QA/SAT001-00 Page 18
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:
HMA/QA/SAT001-00 Page 19
M/S: HMA MEDICAL
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Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
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Dimensional Measurements
Value from
Value from As
Approved
S. No. Description Built - Actual Conclusion
Drawing
(mm)
(mm)
Conclusions
Performed by Checked by
Name
Signature
Date
HMA/QA/SAT001-00 Page 20
M/S: HMA MEDICAL
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Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
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HMA/QA/SAT001-00 Page 21
M/S: HMA MEDICAL
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Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
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TEST Job No.:
Input-Output Checks
Conclusions
Performed by Checked by
Name
Signature
Date
HMA/QA/SAT001-00 Page 22
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
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TEST Job No.:
HMA/QA/SAT001-00 Page 23
M/S: HMA MEDICAL
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Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
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S. No. Results
Test to be Carried Out and
Acceptance Criterion (Pass/Fail) with
Procedure
Sign
Conclusions
Performed by Checked by
Name
Signature
Date
HMA/QA/SAT001-00 Page 24
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:
Conclusions
Performed by Checked by
Name
Signature
Date
HMA/QA/SAT001-00 Page 25
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:
HMA/QA/SAT001-00 Page 26
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
SITE ACCEPTANCE Revision: 00
TEST Job No.:
Conclusions:
HMA/QA/SAT001-00 Page 27
M/S: HMA MEDICAL
LIMITED
Injection Moulding Plant Shanghai Poyton Industry
Co. Ltd.
Document No.:
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12. SAT REPORT APPROVAL
Production
Engineering
Quality Assurance
Administration
Service
HMA/QA/SAT001-00 Page 28