冻干机验证方案

Freeze-dryer Extension Project

SSPC WUXI

VALIDATION PLAN

Freeze Dryer

(GLZ 12)

Author: …………………………………… Xin Juxaing, Validation Team Leader

Reviewed by: …………………………………… Bertil

Boman/Lu Xiaoan, Project Managers

Approved by: …………………………………… Chen Yueyun, Production Manager

Approved by: …………………………………… Ma Tao, QA Manager

List of Contents Page

1INTRODUCTION 3

2BACKGROUND 3

3BRIEF DESCRIPTION OF THE FREEZE DRYER 3 3.1C HAMBER 3

3.2C HAMBER D OORS 3

3.3P RODUCT S HELVES 4

3.4H EAT T RANSFERRING U NIT 4

3.5I CE C ONDENSER 4

3.6M AIN V ALVE 4

3.7V ACUUM S YSTEM 4

3.8R EFRIGERATING U NIT 4

3.9H YDRAULIC S TOPPERING 4

3.10CIP & SIP S YSTEM 4

3.11C ONTROL S YSTEM 5

4SCOPE 5

5VALIDATION TEAM 6

6INSTALLATION QUALIFICATION 6

6.1C HECK OF THE P&ID D RAWING 6

6.2C ALIBRATION OF THE I NSTRUMENTS 6

6.3C HECK OF U TILITIES 6

6.4D OCUMENTATION 6

7OPERATION AND PERFORMANCE QUALIFICATION 6

7.1L EAKING R ATE C HECK 6

7.2H EAT D ISTRIBUTION T EST 6

7.3CIP T EST 6

7.4SIP T EST 6

7.5C APACITY BY W ATER T EST 6

7.6S EALING C HECKING A FTER S TOPPERING 7

7.7F REEZE D RYING C YCLE T EST 7

7.8P LACEBO P ROCESS V ALIDATION (ONLY V ITAMIN C + G LYCINE) 7

8PRODUCT VERIFICATION 7

8.1P RODUCTION V ALIDTION 7

9APPENDIX 7

1 Introduction概述

This Validation Plan (VP) describes the validation intentions for the Freeze Drying machine at the facility of SSPC SVP Freeze Dryer Extension Project, as described in Validation Master Plan 400-VMP-P1. It is written to cover the validation requirements and includes a description of the equipment, process and key functions.

There are two sets freeze dryers of type GLZ-12, made by Beijing Tianli Cryogenic Process Equipment Co. Led will be introduced during freeze dryer extension project. Validation work will be performed separated and there will be validation document number respectively, which is the binder No. 402 and 403.

This VP covers the product of Soluvit N.

A specific Validation Team, has been formed to co-ordinate the joint validation work carried out by the existing plant.

A rough description of the planned tests is described with a time table.

2 Background背景

The process takes place on the first floor in hygienic class B area. The water solution of Vitamin is freezed first. Then the ice is sublimated under very high vacuum during the drying steps.

The whole freeze drying process is controlled by a computerised control system.