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Willkommen in unserem Dokumentationszentrum.

 

Hier finden Sie allgemeine Konformitätserklärungen (CoC) und weitere Dokumente.

Bei Fragen können Sie uns gerne eine Mail schicken an: quality@erweka.com

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ERWEKA ISO Certificate

 Certificate of ERWEKA Management System

 pdfISO9001_ISO14001_DE-08.05.2023.pdf

  pdfISO9001_ISO14001_ENG-08.05.2023.pdf

ERWEKA Declaration of Conformity  (DoC)

Declaration of Conformity

 pdfDoC REACH_V1_18.09.2019_EF.pdf

  pdfDoC RoHS2_18.09.2019_V1_EF.pdf

 Certificates of Compliance (CoC) for ERWEKA Dissolution Testers

Type General Paddle Basket Vessel Shafts
DT 126/128 Light pdfKE_DT12x light V6.pdf pdfKE_Paddle-V20_PTFE.pdf
pdfKE_Paddle-V20_StSt.pdf
pdfKE_Basket V19.pdf  pdfKE_Vessel-V19.pdf pdfKE_Shaft_V3.pdf
DT 72x pdfKE_DT72x V6.pdf
DT 82x pdfKE_DT82x V7.pdf
DT 95x pdfKE_DT95x_V2.pdf
DT 951x pdfKE_DT951x_V2.pdf
DT 141x pdfKE_DT141x_V9.pdf
DT 161x pdfKE_DT161x_V9.pdf
RoboDis II pdfKE_RoboDis_II_V9.pdf
RoboDis II+ pdfKE_RoboDis_II+_V3.pdf
All DT's pdfCertificate ERWEKA Dissolution Vessel interchangeability V4.pdf
pdfKE_Japansinker V11.pdf

 

Certificates of Compliance (CoC) for ERWEKA BioDis RRT 10 Release Rate Tester

Type General
RRT pdfKE_RRT10 V8.pdf

 

 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 pdfKE_DFZ_II V4.pdf pdfKE_DFZ_II_large_Cell V4.pdf pdfKE_DFZ_II_small_Cell V.4.pdf pdfKE_DFZ_II_Suppository_Cell V4.pdf pdfKE_DFZ_II_P+G_Cell V4.pdf

 

Certificates of Compliance (CoC) for Tablet Hardness Testers

Type General
TBH 125/325/425 pdfKE_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 pdfKE_ZT12x_light_V1.pdf pdfKE_ZT-Koerbchen V19.pdf pdfKE_Schwimmduese-ZT V20.pdf pdfKE_ZT-Koerbchen-30mm(EP) V12.pdf pdfKE_Schwimmduese-30mm-ZT(EP) V15.pdf
ZT 220 pdfKE_ZT220_V7.pdf
ZT 320 pdfKE_ZT320_V10.pdf
ZT 720 pdfKE_ZT72x_V5.pdf
ZT 730 pdfKE_ZT73x_V2.pdf

 

Certificates of Compliance (CoC) for Vaccum Leak Testers

Type General
VDT/S pdfKE_VDT_S_V1.pdf

 

Certificates of Compliance (CoC) for Friability-/Abrasion Testers

Type General Friability drum
TAR pdfKE_TARx20 V5.pdf pdfKE_Friabilatortrommel V15.pdf
TAR II pdfKE_TAR_II_V1.pdf  

 

 Certificates of Compliance (CoC) for Powder & Granulate Testers

Type General Other documents
GT/GTB/GTL pdfKE_Granulattester V10.pdf -
SVM 121/221 (stroke 14mm) pdfKE_SVMx21 V7.pdf Measurement Cylinder:
pdfKE_SVM-Messzylinder V6.pdf
SVM 122/222 (stroke 3mm) pdfKE_SVMx22 V7.pdf
SVM II pdfKE_SVM_II_5_in_1_V1.pdf

 

Certificates of Compliance (CoC) for other ERWEKA equipment

Type General Other documents
ST 35 pdfKE_ST35 V5.pdf Apparatus for suppositories and pessaries ("Basket"): pdfKE_ST35_Einsatz V3.pdf
PM30, type "A" pdfKE_PM30_V8.pdf -

 

Certificates for ERWEKA RS Tablets

Batch no. Used for Notes
pdfAPZ_RS-Tabletten_Härte_10.08.2023 Hardness Date of document: 2023-10-08
pdfAPZ_PQ-Tabletten_Friab_EE03025_05_2023.pdf Friability Date of document: 2023-05-16

pdfAPZ_RS-Tabletten_ZT-EH01006_V3.pdf

Disintegration

Date of Document: 2023-12-15

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