Build sterile modules

General :
Version:	1.0

Project :
Author:	Wolfgang Kern
Created:	21.05.2014 16:28:30
Modified:	27.03.2017 10:08:17

Diagram Elements :

Notified Body

Inform NB about release of a new batch including respective certificates

Product containing human blood derivates?

LG Specialist

Stockturn report

Stock for sterile products

Store sterilized modules

Article master data

Label STERILE MEDICAL DEVICE

Label MEDICAL DEVICE

Label lot number

Production process instructions

Sterilization lot report

Manufacturing instructions

Cleaning process instructions

Sterilization Company

Create sterilization report

Module sterilized

Label sterile product

Boxing of sterilized modules

Pack sterilized modules into outer packaging

Sterilize module

Pack module to be sterilized

Assembling of to be sterilized module (if applicable)

Clean parts according to validated cleaning process

Take non-sterile parts from stock

Need to sterilize product