Alfa Laval Toftejorg SaniMidget SB Series, Instruction Manual

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General Description
Instruction Manual, Alfa Laval Toftejorg SaniMidget SB Page 5
IM-TE91A720_EN2
Standard Configurations for SaniMidget SB/3-A
Connection Rotor Article number
1” Clip-on BPE US/ Weld-on DIN Range 1 (ODø28) PEEK 450G 16B132-00
1½” Clip-on BPE US PEEK 450G 16B182-00
1” Weld-on ISO PEEK 450G 16B232-00
1” Weld-on BPE US PEEK 450G 16B233-00
Standard Configurations for SaniMidget SB UltraPure
Connection Rotor Article number
1” Clip-on BPE US/ Weld-on DIN Range 1 (ODø28) PEEK MG* 16B132-05
1” Weld-on ISO PEEK MG* 16B232-05
1” Weld-on BPE US PEEK MG* 16B233-05
Standard Options
Option Article number
Qualification Documentation 16Bxxx-5x
Product Documentation 16Bxxx-9x
Ra 0.5, Electropolished 16Fxxx-xx
*PEEK MG (USP Class VI conforming) was not part of the TPV. As a consequence SaniMidget SB UltaPure has not been
verified to meet the requirements of 3-A Sanitary Standards.
Q-doc
Alfa Laval has made two levels of documentation for Tank
Cleaning Machines, the Product Documentation and the
Qualification Documentation.
Product Documentation consist of:
•
3.1 and USP Class VI Certificates
•
FDA Declaration of Conformity
•
TSE Declaration and QC Declaration of Conformity
The
Qualification Documentation is designed for the BioPharm
and Personal Care industry and contains all necessary
documents for qualification of Alfa Laval hygienic Tank Cleaning
Machines. All documents are developed in according to the ISPE
V-model and GDP, Good Documentation Practice, and includes:
•
RS, Requirement Specification.
•
DS, Design Specification incl. Traceability Matrix.
•
FAT, Factory Acceptance Test incl. IQ & OQ.
•
3.1 and USP Class VI Certificates.
•
FDA Declaration of Conformity.
•
TSE Declaration and QC Declaration of Conformity.
•
SAT, Site Acceptance Test Protocol incl. IQ & OQ for
End-User Execution.