ERWEKA ISO Certificate
| Certificate of ERWEKA Management System |
ERWEKA Declaration of Conformity (DoC)
| Declaration of Conformity |
Certificates of Compliance (CoC) for ERWEKA Dissolution Testers
| Type | General | Paddle | Basket | Vessel | Shafts | ||
| DT 126/128 Light |  KE_DT12x light V6.pdf |
KE_Paddle-V20_PTFE.pdf KE_Paddle-V20_StSt.pdf |
KE_Basket V19.pdf |
KE_Vessel-V19.pdf |
KE_Shaft_V3.pdf |
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| DT 72x | KE_DT72x V6.pdf |
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| DT 82x | KE_DT82x V7.pdf |
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| DT 95x | KE_DT95x_V2.pdf |
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| DT 951x | KE_DT951x_V2.pdf |
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| DT 141x | KE_DT141x_V9.pdf |
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| DT 161x | KE_DT161x_V9.pdf |
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| RoboDis II | KE_RoboDis_II_V9.pdf |
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| RoboDis II+ | KE_RoboDis_II+_V3.pdf |
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| All DT's | Certificate ERWEKA Dissolution Vessel interchangeability V4.pdf KE_Japansinker V11.pdf |
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Certificates of Compliance (CoC) for ERWEKA BioDis RRT 10 Release Rate Tester
| Type | General | ||
| RRT | KE_RRT10 V8.pdf |
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Certificates of Compliance (CoC) for ERWEKA Flow-Through-Cell Tester DFZ II (USP 4)
| Type | General | Large cell | Small cell | Cell for lipophilic dosage forms | Cell for powder and granulas | |||
| DFZ II | KE_DFZ_II V4.pdf |
KE_DFZ_II_large_Cell V4.pdf |
KE_DFZ_II_small_Cell V.4.pdf |
KE_DFZ_II_Suppository_Cell V4.pdf |
KE_DFZ_II_P+G_Cell V4.pdf |
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Certificates of Compliance (CoC) for Tablet Hardness Testers
| Type | General |
| TBH 125/325/425 | KE_TBH_V9.pdf |
Certificates of Compliance (CoC) for ERWEKA Disintegration Testers ZT
Type |
General |
Basket Type "A", 6-pos. | Basket Type "B", 3-pos. | ||
| Basket | Disk | Basket | Disk (31,4mm) | ||
| ZT 120 | KE_ZT12x_light_V1.pdf |
KE_ZT-Koerbchen V19.pdf |
KE_Schwimmduese-ZT V20.pdf |
KE_ZT-Koerbchen-30mm(EP) V12.pdf |
KE_Schwimmduese-30mm-ZT(EP) V15.pdf |
| ZT 220 | KE_ZT220_V7.pdf |
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| ZT 320 | KE_ZT320_V10.pdf |
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| ZT 720 | KE_ZT72x_V5.pdf |
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| ZT 730 | KE_ZT73x_V2.pdf |
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Certificates of Compliance (CoC) for Vaccum Leak Testers
| Type | General |
| VDT/S | KE_VDT_S_V1.pdf |
Certificates of Compliance (CoC) for Friability-/Abrasion Testers
| Type | General | Friability drum |
| TAR | KE_TARx20 V5.pdf |
KE_Friabilatortrommel V15.pdf |
| TAR II | KE_TAR_II_V1.pdf |
Certificates of Compliance (CoC) for Powder & Granulate Testers
| Type | General | Other documents |
| GT/GTB/GTL | KE_Granulattester V10.pdf |
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| SVM 121/221 (stroke 14mm) | KE_SVMx21 V7.pdf |
Measurement Cylinder:KE_SVM-Messzylinder V6.pdf |
| SVM 122/222 (stroke 3mm) | KE_SVMx22 V7.pdf |
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| SVM II | KE_SVM_II_5_in_1_V1.pdf |
Certificates of Compliance (CoC) for other ERWEKA equipment
| Type | General | Other documents |
| ST 35 | KE_ST35 V5.pdf |
Apparatus for suppositories and pessaries ("Basket"): KE_ST35_Einsatz V3.pdf |
| PM30, type "A" | KE_PM30_V8.pdf |
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Certificates for ERWEKA RS Tablets
| Batch no. | Used for | Notes |
| APZ_RS-Tabletten_Härte_10.08.2023 |
Hardness | Date of document: 2023-10-08 |
| APZ_PQ-Tabletten_Friab_EE03025_31.12.2024.pdf |
Friability (Extension) | Date of document: 2023-06-20 |
| APZ_PQ-Tabletten_Friab_EK01009_31.08.2025.pdf |
Friability (new) | Date of document: 2024-08-30 |
| Disintegration |
Date of Document: 2023-12-15 |
