1. Purpo: To establish the validation procedure for purified water preparation
system, standardize the validation of the purified water preparation
system and ensure the correct and reliable results of the validation
implementation.
2. Scope of Application: This procedure is applicable for the validation management
of the purified water preparation system.
3. Responsibility: The Quality Department is responsible for formulating this
procedure, and the Vice General Manager for Production Quality,
the Quality Department, the Production Department and the
Equipment Engineering Department are responsible for
implementation of this procedure.
4. Contents:
4.1 Validation purpos: The validation of the purified water preparation system aims
to investigate that the purified water preparation system can stably supply
specified quantity and quality of qualified water in all kind of possible situations in future, so as to meet the requirements for production process and the
requirements of health food GMP.
4.2 Requirements of validation documents
4.2.1 In accordance with the requirements of the Validation Management Procedure,
the validation documents of the purified water preparation system shall have the unified format (including the first page, contents and main body) as required.
疫情在家作文4.2.2 For the newly installed purified water preparation system, the pre-confirmation
part in the validation program shall be independently prepared and approved for implementation, and after the pre-confirmation report has been approved, other
validation items can be proceeded.
4.3 Preparation of the main body of the validation program on the purified water
preparation system: the main body includes the following contents:
4.3.1 The purpo of the validation program, namely why to draft this program.
4.3.2 Description of validation objects, namely the background outline and compod
basic functions of the validation objects.
4.3.3 Departments of the validation implementation and division of the relevant
persons.
4.3.4 Validation schedule.
4.3.5 Standard operating procedures related to validation and reference materials
including the name, number and specified storage location.
4.3.6 Validation steps
4.3.6.1 Pre-confirmation
4.3.6.1.1 Design and model lection of the purified water preparation system. Bad
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on performance and parameter ttings and by referring to the system
manual, it targets at investigating if it meets the requirements of production
process, calibration, repair, maintenance and cleaning, and a written report
shall be propod. The main factors to be considered are as follows:
4.3.6.1.1.1 Flowchart of the purified water preparation system:
4.3.6.1.1.2 Basic requirements of the purified water preparation system
a Provide purified water pre-treatment equipment according to the
source water quality;
b The multi-media mechanical filter and water softener can perform
automatic backflush, regeneration or discharge;
c The active carbon filter is a place concentrate
d with organics. In
order to prevent contamination from bacteria and bacterial
endotoxin, it is required not only to conduct automatic backflush but
also make disinfection with steam or ozone.
d If it is equipped with UV sterilization devices, becaus
e the light
intensity of 255nm (2537 Å) wavelength stimulated by UV is
inverly proportional to time, it is required to have an instrument
recording time;
e The purified water pasd through deionizers such as the mix bed
must be recycled so as to make the water quality stable;分享ppt
4.3.6.1.1.3 Requirem ents of the purified water preparation equipment: 3.0 μm water
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filters must be installed at the inlet of the rever osmosis device.
4.3.6.1.1.4 Basic requirements of the water container (water tank)
a It is made of 316L stainless steel with the inner wall electrically
polished and passivated;
b The 0.2 μm hydrophobi
c ventilation filter (respirator) shall be installed
on the water tank;
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c The stainless steel diaphragm valve shall be u
d for th
e drain valve;
4.3.6.1.1.5 Requirements of pipelines and the distribution system
a It is made from 316L stainless steel pipes with the inner wall
electrically polished and passivated;
b The pipelines shall be connected by hot-melting-type argon arc
welding, or connected by gmentation with sanitary clamps;
c Pipelines shall be installe
d at a certain inclination so as to facilitate
drainage;
d Th
e employed valves shall adopt stainless steel PTFE diaphragm
valves connected by sanitary clamps;
e The Pipes shall be laid with loops, the backwater can flow to the
storage tank, and pipes can be connected in ries;
f Pipelines shall be disinfected by ozone for 30 minutes.
4.3.6.1.1.6 Basic requirements for purified water pumps
a It is made of 316L stainless steel (the immerd part) which is
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electrically polished and passivated;
b U sanitary clamps as the connector;
c U purifie
d water itlf as th
e lubricant;
4.3.6.1.1.7 Supplier’s qualification and audit results shall be in line with r equirements;
4.3.6.2 Installation confirmation
4.3.6.2.1 The installation of the purified water preparation system shall be in line with
required documents and the corresponding record tables and approved
results shall be attached.
a Flowcharts, system description and design parameters accepted by
the Quality Department or the Equipment Engineering Department;
b Records on water treatment equipment and pipeline installation
commissioning;
c Validation records of instruments;
d Operation manuals of equipment and procedures of standard
operation and maintenance.
4.3.6.2.2 The main contents of installation of the purified water preparation system
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shall be confirmed and the corresponding record tables and approved results
shall be attached.
4.3.6.2.2.1 Installation confirmation of purified water equipments and devices.
The installation confirmation of purified water preparation equipments and
devices refers to checking if the installation is in line with the design and
specification by comparing with the design drawings and technical data
provided by suppliers after equipment installation. Inspection items are as
follows: installation and connection situations, including electrical devices,
connecting pipelines, instruments, water supply, filters, rever osmosis
devices and etc.
4.3.6.2.2.2 Installation confirmation of the pipes distribution system
a Materials of pipes and valves. Selected pipes shall be made of
stainless steel which is characterized by being chemical inert and
easy to be disinfected as well as having a wide working temperature
range.
b Connection and pressure test of pipes. The purified water pipes
shall be connected by the hot-melting-type argon arc welding and the
inner wall of pipes shall be smooth; in the meanwhile, check the
welding quality, record the number of welding joints, and take X-ray
films. Becau it is difficult to take X-ray films of the interlayer of a
pipe, X-ray film can be taken in advance. Generally, the automatic
argon arc hot-melting welding machine is adopted, and the welding
control parameters such as current, frequency and etc. shall be
determined upon the corresponding equipment manuals; after that, a
number of joints can be provided with help of above obtained
parameters, and X-ray films can be taken before installation (if
impossible, X-ray films can be outsourced). If requirements are met,
then the parameters can be controlled within the range of this step, so
as to ensure the welding joints flat and smooth; after welding,
pressure test shall be conducted with deionized water, the test
pressure is 1.5 times of the working pressure; no leakage is regarded
as qualification.
c Cleaning, passivation an
d disinfection of pipes. Th
e treatment of
stainless steel pipes can be roughly divided into the following
categories:
Purified water cycle pre-flushing, Alkaline cleaning, flushing,
passivation, initial flushing, final flushing and sterilization with pure
steam.
d Th
e integrity tests must be conducted for all kinds o
f ventilation filters
installed on the water tank.
4.3.6.2.3 Calibration of instruments
All instruments on the purified water treatment devices must be calibrated or
accepted regularly so as to make errors to be controlled within the allowed
日记100个字range; the common instruments ud for purified water treatment are as
follows: time controllers of the resistance (conductivity) meter, flow meters,
