Brinyte’s diving flashlight CASS test report
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This document is a test report summarizing corrosion resistance testing of diving lights from Shenzhen Yeguang Technology Co., Ltd. It includes: - Details of the sample, applicant, manufacturer, test items, and test dates - Results showing the samples passed a CASS (Corrosion Accelerated Salt Spray) test without any visual damage after 48 hours in a salt spray chamber at 50°C with NaCl and CuCl2 fog - Descriptions of the CASS test method and pass/fail criteria used to evaluate the samples
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Quality DocumentationDocumentation OverviewThe Q.docx
Quality Documentation
Documentation Overview
The Quality Manual
Types of Quality Documentation
Quality Documentation
Four Attributes of GMP Documentation
Types of Documents
SOP: Standard Operating Procedure
Examples of SOP Categories
Typical SOPs
Components of an SOP
Control of SOPs
Control of SOPs
Raw Material Specifications
Raw Materials
Raw Materials Example
Product Specifications
Master/Batch Production and
Control Records
Master/Batch Production Records
EBR
Laboratory Records
Equipment Cleaning and Use Logs
Equipment Log Example
Distribution Records
Complaint Files
Document Format
Why All The Documentation
Everything you always wanted to know about good documentation but were afraid someone might tell you
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Good Documentation Practices
Everything you always wanted to know about good documentation but were afraid someone might tell you
ENTRIES
ELECTRONIC RECORDS
ELECTRONIC RECORDS (con’t)
ELECTRONIC RECORDS (con’t)
COUGAR Pharmaceuticals
Proprietary Information
Project Name: Magnetic Particle Real Time Stability Protocol
Project Number:1002
Protocol Number: QCSASS-03
Date: 7/16/01 Page: 4 of 9
Originator Approval
Date:
R&D Approval
Date:
QC Approval
Date:
QA Approval
Date:
Regulatory Affairs Approval
Date
TABLE OF CONTENTS
21
Study Overview
2
Materials/Methods
3
3
Data Recording and Analysis
5
4
Interpretation of Results
5
5
Reagent Requirements
6
6
Validity Criteria
6
7
Repeat Testing Criteria
6
8
Failure Investigation
7
9
Appendix B: Stability Study Deviation Log
8
10
APPENDIX B: SUMMARY OF MATERIALS AND METHODS
9
Magnetic Particles for Target Capture Reagent
9
1 Study Overview1.1 Objectives
1.2 The objective of this protocol is to provide stability data to support the dating of the Seradyn Magnetic Particles and dT14 Magnetic Particles used in the manufacture of the Target Capture Reagent in the TMA HIV-1/HCV Assay master kit. These Magnetic Particles are stored for extended periods after manufacture but prior to final reagent formulation. In addition, data will be generated to show the Raw Material/Subassembly stay within specification when stored under the recommended conditions during proposed storage times as defined in the QS or QCS documents.
1.3 Definitions
1.3.1 Component: Global term to identify any labeled reagent, subassembly or raw material.
1.3.2 Raw Material: Component manufactured by outside Vendor that is used in manufacture of a second component.
1.3.3 Real Time Stability Study: Subassemblies are incubated at their proposed long term storage temperature for a period of time exceeding the proposed shelf life of the product by at least 20%.
1.3.4 Subassembly: Intermediates in the manufacturing process of the labeled reagents.
1.4 ...
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2) Chlorine was detected at 151 mg/kg but no other halogens were found.
3) All other substances tested including phthalates, polyar
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- 1. No.: DZ1406270418 TEST REPORT Sample Name: Diving light Applicant Name: Shenzhen Yeguang Technology Co., Ltd. Manufacturer: Shenzhen Yeguang Technology Co., Ltd. Supplier: / Buyer: / Shenzhen Yitong Testing Technology Co., Ltd
- 2. TEST REPORT No.: DZ1406270418 Date: Jun 27, 2014 Page 1 Of 7 Applicant Name: Shenzhen Yeguang Technology Co., Ltd. Address: Emerson Building A, 26 Zone, Bao’an District, Shenzhen City, Guangdong Province, China Sample Information Sample Name: Diving light Sample No.: ZH1406230418 Sample Model: / Sample Size: / Sample Weight: / Sample Quantity: 11PCS Sample Description: Normal Manufacturer: Shenzhen Yeguang Technology Co., Ltd. Test Information Test Item: CASS Test Receive Date: Jun 20, 2014 Testing Date: Jun 24, 2014 to Jun 26, 2014 Preconditioning: / Test Result Pass. After the test, there is no appearance damage on all samples by visual inspection. Authorized: Checked: Tested:
- 3. No.: DZ1406270418 Date: Jun 27, 2014 Page 2 Of 7 Test Item 1: CASS Test 1. Test Standard: GB/T 10125-2012 2. Test Equipment: Equipment Name Equipment Model Equipment NO. Calibration Useful-life Salt Spray Corrosion Test Chamber YWX/Q-250 TTS-YQ-064 Jan 20, 2015 3. Test Remark & Notes: Place the samples into the Salt Spray Corrosion Test Chamber, the test condition is as below: (1) Mix (5±1)% concentration NaCl and (0.26±0.02)g/L concentration CuCl2·2H2O, the PH value is 3.1. (2) The air pressure of the fog chamber is 98kPa, temperature inside the fog chamber is (50±2)℃. (3) The test duration is 48h. (4) The quantity of salt fog is 1.2ml/h·80cm2 . (5) Clean the samples with running water and then check them by visual inspection.
- 4. No.: DZ1406270418 Date: Jun 27, 2014 Page 3 Of 7 Appendix: Test Pictures Pre-test:
- 5. No.: DZ1406270418 Date: Jun 27, 2014 Page 4 Of 7 The Samples
- 6. No.: DZ1406270418 Date: Jun 27, 2014 Page 5 Of 7 Testing: CASS Test Post-test:
- 7. No.: DZ1406270418 Date: Jun 27, 2014 Page 6 Of 7
- 8. No.: DZ1406270418 Date: Jun 27, 2014 Page 7 Of 7 No appearance damage on all samples - - - END OF THE REPORT - - -