Tabla de contenido
Fabrication Nº:
Equipment:
OPERATING INSTRUCTIONS AND MAINTENANCE MANUAL
9
START-UP AND OPERATION ............................................................................... 42
9.1 START OF OPERATION ..................................................................................... 42
9.2 RECIRCULATION OPERATIONS ......................................................................... 42
9.3 PRELIMINARY SETTINGS .................................................................................. 47
9.3.1
Setting the drain times ......................................................................................... 47
9.3.2
Spill setting .......................................................................................................... 47
9.3.3
Setting the maximum weight oscillation .............................................................. 48
9.4 EXTERNAL MEMORY ........................................................................................ 48
9.5 LIGHT OPERATION ........................................................................................... 48
9.6 TOUCH-SCREEN OPERATION ........................................................................... 49
9.6.1
Program structure ................................................................................................ 49
9.6.2
OVERVIEW screen (Process / Recipe) ................................................................... 50
9.6.3
RECIPE screen ...................................................................................................... 53
9.6.4
ALARMS screen .................................................................................................... 55
9.6.5
CHARTS screen..................................................................................................... 56
9.6.6
PROGRAM SETTINGS screen ................................................................................. 57
9.6.7
HMI SETTINGS screen ........................................................................................... 62
9.6.8
USER SETTINGS screen ........................................................................................ 63
9.7 COMPLIANCE WITH 21 CFR, PART 11 ............................................................... 64
9.7.1
Introduction .......................................................................................................... 64
9.7.2
Identification and authentication of users ............................................................ 64
9.7.3
Automatic log-off .................................................................................................. 64
9.7.4
Actions register .................................................................................................... 65
9.7.5
Audit Trail evaluation ........................................................................................... 66
10 MAINTENANCE AND CLEANING .......................................................................... 68
10.1
BASIC MAINTENANCE .................................................................................. 68
10.2
MOTORS ..................................................................................................... 69
10.3
GEAR UNITS ................................................................................................ 70
10.4
TIGHTNESS SEALS ....................................................................................... 70
10.5
DRY MECHANICAL SEAL............................................................................... 71
10.6
EQUIPMENT CLEANING ................................................................................ 72
10.7
SPARE PARTS LIST - VCR 1002 .................................................................... 74
10.8
SPARE PARTS LIST - MET 0400 .................................................................... 76
Ref. ProJect / Revision:
721021-07 / R01
721021-70-1 / 721021-70-3
VESSEL FOR CREAMS - Mod. VCR 1002 / MELT TANK - Mod. MET 0400
Client:
UNIPHARMA
Date:
11-2015
EN
ES
MDI VCR (v1.0)
4 of 153
Capítulos
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