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Test Services
Medical
Microbiological (12)
Physical (17)
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Sterilization (11)
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Validation (1)
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Validation (1)
Sterility Test ( Direct Inoculation Method)
(CDM0001)
Standard: USP,EP, ISO 11737-2 Sample: 4 Time: 15 days
Bioburden Test
(CDM0002)
Standard: ISO 11737-1 Sample: 4 Time: 8 days
Bacterial Endotoxin Test (LAL)
(CDM0003)
Standard: EP.2.6.14, USP NF (85), USP NF (161), Sample: 4 Time: 2 days
Surface Biocontamination Test - Personnel
(CDM0005)
Standard: TS EN ISO 14698-1, TS EN ISO 14698-2 Sample: 1 Time: 10 days
In Vitro Cytotoxicity Test
(CDM0004)
Standard: TS EN ISO10993-5 TS EN ISO10993-12 Sample: 5 Time: Ask
Surface Biocontamination Test - Personnel
(CDM0006)
Standard: TS EN ISO 14698-1, TS EN ISO 14698-2 Sample: 1 Time: 10 days
Surface Biocontamination Test
(CDM0007)
Standard: TS EN ISO 14698-1, TS EN ISO 14698-2 Sample: 1 Time: 10 days
Active Air Contamination Test
(CDM0008)
Standard: TS EN ISO 14698-1, TS EN ISO 14698-2 Sample: 1 Time: 10 days
Passive Air Biocontamination Test
(CDM0009)
Standard: TS EN ISO 14698-1, TS EN ISO 14698-2 Sample: 1 Time: 10 days
Biological Indicator Sterility Test
(CDM0010)
-
Bacterial Filtration Efficiency Test (BFE) Medical Face Mask
(CDM0011)
Standard: BS EN 14683 – ASTM F2101 – TSE K 599 Sample: 10 masks or material (10x10cm) Time: 3 days
Medical Face Mask Test -Grup (BFE – Dif.Pressure– Bioburden)
(CDM0012)
Standard: BS EN 14683 – ASTM F2101 – TSE K 599 – ISO 11737-1 Sample: 30 masks and materials (10x10cm) Time: 10 gün
Packaging Leakage Test (Dye)
(CDF0001)
Standard: ASTM F 1929-15 Sample: 2 Time: 2 days
Packaging Leakage Test (Bubble)
(CDF0002)
Standard: ASTM F2096 Sample: 2 Time: 2 days
Package Seal Strength Test
(CDF0003)
Standard: TS EN 868-5, ASTM F88 / F88M-15 Sample: 2 Time: 2 days
Syringe Performance Test (Test of Determination of Piston Mobility Force)
(CDF0004)
Standard: ISO 7886-1.2017 EK-E Sample: 2 Time: 2 days
Syringe Performance Test (Air Leakage Test)
(CDF0005)
Standard: - Sample: - Time: 2 days
Tensile Test (Special)
(CDF0006)
-
Shear Test (Special)
(CDF0007)
-
Compression Test (Special)
(CDF0008)
-
Differantial Pressure Test (Breathing Capability) - Medical Face Mask
(CDF0009)
Standard: BS EN 14683 –TSE K 599 Sample: 10 masks or material (10x10cm) Time: 3 days
Tensile Strength Elongation Determination Test for Nonvoven Fabrics
(CDF0010)
Standard: EN 14683 Sample: Ask Time: 3 days
Linear Measurement Test - Packaging Material
(CDF0011)
Standard: ASTM F2203 Sample: Ask Time: 2 days
Accelerated Aging Test (1 Year)
(CDK0003)
Standard: ASTM F1980-16 Sample: Ask Time: 26 days (58 °C) Aging time was calculated according to 20 ° C storage conditions.
Accelerated Aging Test (2 Year)
(CDK0004)
Standard: ASTM F1980-16 Sample: 4 Time: 65 Days (58 °C) Explanation: Aging time was calculated according to 20 ° C storage conditions.
Accelerated Aging Test (3 Year)
(CDK0005)
Standard: ASTM F1980-16 Sample: 4 Time: 79 Days (58 °C) Aging time was calculated according to 20 ° C storage conditions.
Accelerated Aging Test (4 Year)
(CDK0006)
Standard: ASTM F1980-16 Sample: 4 Time: 105 days (58 °C) Aging time was calculated according to 20 ° C storage conditions.
Accelerated Aging Test (5 Year)
(CDK0007)
Standard: ASTM F1980-16 Sample: 4 Time: 131 Days (58 °C) Aging time was calculated according to 20 ° C storage conditions.
Real Time Aging Test
(CDK0008)
-
Oil Residue Test
(CDK0001)
Standard: SM5520-B / ASTM F2459- 12 Sample: 2 Time: 2 days
Detergent Residue Test
(CDK0002)
Standard: ISO 2271 / ASTM F2459-12 Sample: 2 Time: 2 days
Accelerated Aging Test (1 Year)
(CDK0003)
Standard: ASTM F1980-16 Sample: Ask Time: 26 days (58 °C) Aging time was calculated according to 20 ° C storage conditions.
Accelerated Aging Test (2 Year)
(CDK0004)
Standard: ASTM F1980-16 Sample: 4 Time: 65 Days (58 °C) Explanation: Aging time was calculated according to 20 ° C storage conditions.
Accelerated Aging Test (3 Year)
(CDK0005)
Standard: ASTM F1980-16 Sample: 4 Time: 79 Days (58 °C) Aging time was calculated according to 20 ° C storage conditions.
Accelerated Aging Test (4 Year)
(CDK0006)
Standard: ASTM F1980-16 Sample: 4 Time: 105 days (58 °C) Aging time was calculated according to 20 ° C storage conditions.
Accelerated Aging Test (5 Year)
(CDK0007)
Standard: ASTM F1980-16 Sample: 4 Time: 131 Days (58 °C) Aging time was calculated according to 20 ° C storage conditions.
Real Time Aging Test
(CDK0008)
-
PH Test
(CDK0009)
Standard: 4500 H+ Time : 2 days Sample: 200 ml
Total Organic Carbon (TOC) Test
(CDK0010)
TOC
Total Hydrocarbon (THC) Test
(CDK0011)
THC
Cytotoxicity Test (İn-vitro)
(CDB0001)
Standard: ISO 10993-5
Irritation Test
(CDB0002)
Irritation Test
Sensitization Test
(CDB000)
Sensitization Test
Bacterial Endotoxin Test (LAL)
(CDM0003)
Standard: EP.2.6.14, USP NF (85), USP NF (161), Sample: 4 Time: 2 days
Personnel Biocontamination Test
(CDM0005)
Standard: TS EN ISO 14698-1, TS EN ISO 14698-2 Sample: 1 Time: 10 days
Surface Biocontamination Test - Personnel
(CDM0006)
Standard: TS EN ISO 14698-1, TS EN ISO 14698-2 Sample: 1 Time: 10 days
Surface Biocontamination Test
(CDM0007)
Standard: TS EN ISO 14698-1, TS EN ISO 14698-2 Sample: 1 Time: 10 days
Active Air Contamination Test
(CDM0008)
Standard: TS EN ISO 14698-1, TS EN ISO 14698-2 Sample: 1 Time: 10 days
Passive Air Biocontamination Test
(CDM0009)
Standard: TS EN ISO 14698-1, TS EN ISO 14698-2 Sample: 1 Time: 10 days
Biological Indicator Sterility Test
(CDM0010)
-
PH Test
(CDK0009)
Standard: 4500 H+ Time : 2 days Sample: 200 ml
E.Coli Test
(CDM0013)
Standard: ISO 16649-2 / ISO 7218 Sample: Ask Time: Ask
PH Test
(CDK0009)
Standard: 4500 H+ Time : 2 days Sample: 200 ml
Ethylene Oxide Validation (Automatic System)
(CV10001)
Standard: TS EN ISO 11135
Ethylene Oxide Validation (Cartridge System)
(CV10002)
Standard: TS EN ISO 14937 ve TS EN ISO 11135
Gamma Sterilization Validation
(CV10003)
Standard: ISO 11137-1/2
E-Beam Sterilization Validation
(CV10004)
Standard: ISO 11137-1/2
Steam Sterilization Validation of Medical Product
(CV10005)
Standard: ISO 17665-1
Depyrogenization Tunnel Qualification
(CV10013)
Standard: Ask
Dry Heat Sterilization Qualification
(CV10014)
Standard: TS EN ISO 20857, PDA Technical Report No:3 -Validation of Dry Heat Processes Used for Sterilization and Depyrogenation
Hydrogen Peroxide Sterilization Validation
(CV10015)
Standard: Ask
Autoclave Performance Qualification
(CV10016)
ISO 13060 – EN 285
Compressed Air Quality Validation
(CV10017)
Standard: ISO 8573-1
Washing and Disinfector Validation
(CV10018)
-
Packaging Validation
(CV10006)
Standard: ISO 11607
Cleaning Validation (Production)
(CV10007)
Standard: Ask
Cleaning Validation of Reusable Medical Devices
(CV10007-1)
Cleaning Validation of Reusable Medical Devices
Computer System Validation - Equipment
(CV10008)
Standard: Ask
Computer System Validation – Medical Product
(CV10009)
Standard: Ask
Transport Adaptation Validation
(CV10010)
Standard: Ask
Temperature and Humidity Mapping (Stability Room)
(CV10011)
Standard: TS EN IEC 60068-3-5 TS EN IEC 60068-3-6 TS EN IEC 60068-3-7 EudraLex Volume 4 Annex 15 GMP Medicinal Products for Human and Veterinary Use EU Guideline on Good Distribution Practice of Medicinal Products For Human Use WHO Technical Report Series No.961, Annex 9 Supplement 7,8 FDA 21 CFR Part 11
Temperature and Humidity Mapping (Storage Areas, Cold Room)
(CV10012)
Standard: EU Guideline on Good Distribution Practice of Medicinal Products For Human Use WHO Technical Report Series No.961, Annex 9 Supplement 7, 8 FDA 21 CFR Part 11
E-Beam Sterilization Validation
(CV10004)
Standard: ISO 11137-1/2
Depyrogenization Tunnel Qualification
(CV10013)
Standard: Ask
Dry Heat Sterilization Qualification
(CV10014)
Standard: TS EN ISO 20857, PDA Technical Report No:3 -Validation of Dry Heat Processes Used for Sterilization and Depyrogenation
Hydrogen Peroxide Sterilization Validation
(CV10015)
Standard: Ask
Autoclave Performance Qualification
(CV10016)
ISO 13060 – EN 285
Compressed Air Quality Validation
(CV10017)
Standard: ISO 8573-1
Washing and Disinfector Validation
(CV10018)
-
Packaging Validation
(CV10006)
Standard: ISO 11607
Cleaning Validation
(CV10007)
Standard: Ask
Temperature and Humidity Mapping (Stability Room)
(CV10011)
Standard: TS EN IEC 60068-3-5 TS EN IEC 60068-3-6 TS EN IEC 60068-3-7 EudraLex Volume 4 Annex 15 GMP Medicinal Products for Human and Veterinary Use EU Guideline on Good Distribution Practice of Medicinal Products For Human Use WHO Technical Report Series No.961, Annex 9 Supplement 7,8 FDA 21 CFR Part 11
Temperature and Humidity Mapping (Storage Areas, Cold Room)
(CV10012)
Standard: EU Guideline on Good Distribution Practice of Medicinal Products For Human Use WHO Technical Report Series No.961, Annex 9 Supplement 7, 8 FDA 21 CFR Part 11
Depyrogenization Tunnel Qualification
(CV10013)
Standard: Ask
Dry Heat Sterilization Qualification
(CV10014)
Standard: TS EN ISO 20857, PDA Technical Report No:3 -Validation of Dry Heat Processes Used for Sterilization and Depyrogenation
Temperature and Humidity Mapping (Stability Room)
(CV10011)
Standard: TS EN IEC 60068-3-5 TS EN IEC 60068-3-6 TS EN IEC 60068-3-7 EudraLex Volume 4 Annex 15 GMP Medicinal Products for Human and Veterinary Use EU Guideline on Good Distribution Practice of Medicinal Products For Human Use WHO Technical Report Series No.961, Annex 9 Supplement 7,8 FDA 21 CFR Part 11
Temperature and Humidity Mapping (Storage Areas, Cold Room)
(CV10012)
Standard: EU Guideline on Good Distribution Practice of Medicinal Products For Human Use WHO Technical Report Series No.961, Annex 9 Supplement 7, 8 FDA 21 CFR Part 11
Clean Room Installation Services
(CDA10001)
Standard: GMP, ISO 14644 series, ISO 13485
Sterilization Process Designe and sterilizer Selection
(CDA10002)
-
Cleaning Process Designe and Determination of Methods
(CDA10003)
-
Clean Room Installation Services
(CDA10001)
Standard: GMP, ISO 14644 series, ISO 13485
Sterilization Process Designe and sterilizer Selection
(CDA10002)
-
Cleaning Process Designe and Determination of Methods
(CDA10003)
-
Basic Validation and Qualification (For Manufacturer)
(CE10002)
-
Sterilization Process
(CE10001)
-
Basic Validation and Qualification (For Manufacturer)
(CE10002)
-
Sterilization Process
(CE10001)
-
Basic Validation and Qualification (For Manufacturer)
(CE10002)
-
Control
Approval and Sent
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About us
Test
Medical Device
Pharmaceutical
Cosmetics Tests
Hospital
Biocompatibility Tests
Chemical Characterization
Validation
Sterilization Validation
Cleaning Validation
Manufacturing Processes Validation
Software Validation
Equipment Qualification
Compressed Air System Validation
Cleanroom Validation
Sectoral
Consultancy Services
Education Services
Special Tests
Quality
Quality Management
Privacy & Neutrality
Customer Complaints
Quality Certificates
Contact Us
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