Distilled water machine is the main equipment for the production of water for injection in the pharmaceutical industry. It has been greatly improved through the practice of GMP transformation projects for many years. With the release of new domestic GMP and people's awareness of EU GMP, pharmaceutical companies choose the distilled water machine. The requirements are also getting higher and higher. This article will elaborate on the basic requirements for the selection of distilled water machines.

1 Basic requirements of equipment 1.1 Materials / surface (1) Surfaces that are not in contact with the product and clean medium: The surface is smooth, easy to clean, and does not react with cleaning agents and disinfectants. The material is at least 304.

(2) Surface in contact with the product and clean medium: surface roughness (Ra 0.4 μm), electropolishing, roughness measurement report, material 316L, material proof.

1.10 Distillate Cooler Distillate cooler should be a hygienic double tube tube tube design with seamless tubing. For leak testing, slots or drain holes are required between the inner and outer tubes.

1.11 Water tank for injection (1) Water tank for injection should include liquid level switch, temperature, liquid level transmitter, conductivity display, electric heating filter, 0.22μm air filter and spray ball.

(2) Part in contact with the product and clean medium: The water for injection tanks and fittings is made of 316L or equivalent, and the inner surface should be free of cracks, and the polishing degree is Ra 0.4μm or higher. The in-tank design is easy and thorough to clean, as all edges are rounded.

(3) The storage tank should be designed for heat preservation, with automatic jacket (steam) heating and insulation, and the temperature inside the tank should not be lower than 80 °C.

(4) The tank should be completely emptied without condensate and water remaining.

(5) Manholes (DN500) are required for storage tanks.

2 Basic requirements of the process 2.1 Basic requirements of the multi-effect distillation process 2.2 Emergency accidents are automatically shut down, and the medium and energy supply are automatically shut down.

3 Pipeline / valve / installation basic requirements 3.1 Pipe / valve and product and clean medium contact parts: (1) all water for injection pipe material is 316L or equivalent material, the internal surface polishing degree Ra 0.4μm or higher; (2) All pipelines have a slope of not less than 1%, the drain valve is installed at the low point of each section of the pipeline, and the drain valve is connected to the flange connection; (3) the water injection system controls the return flow rate to be no less than 1.5 m/s; (4) All pipes and installations should be free of dead ends and can be completely emptied. The distance between the draining pipe and the floor drain of the water for injection system is at least 25 mm.

3.2 The installation is consistent with the P&ID (flowchart) and consistent with the construction drawing. The self-controlled installation protection level of the instrument box is in accordance with NEMA4x/IP65.

4 Electrical / Automation / Data Acquisition Technology and Computer Verification 5 Required Documents The table below lists all the documents required for this project. All documents are subject to review and the documents to be approved are marked A. Approved before or at the time of the specified project milestone.

file
milestone
1
Project and certification program milestones
A
Order confirmation
2
Flow chart
A
DQ
3
Detailed floor plan, including all dimensions, interfaces and utility connections (pdf and dwg version)
A
DQ
4
Design specification
A
DQ
5
Supplier Safety Analysis (according to EN 1050)
Failure mode and impact analysis method (data)
DQ
6
Equipment Supplier Change Management (all approval documents)
DQ (FAT review)
7
Functional Planning (PCS) according to international and domestic standards, including user interface, mechanical control logic, alarm description, electrical and pneumatic charts
A
DQ
8
Line Integration and Security Features PCS Chart
A
DQ
9
Terminal plan, wiring icons and component list
A
DQ
10
All part size drawings and parts usage specifications
A
DQ
11
Zui final version file directory
DQ
12
Startup, Operation, Maintenance, Disassembly, and Troubleshooting
A
FAT
13
List of all lubricants
A
FAT
14
List of parts/materials in direct contact with the product (only for thermoformed materials), including material certificates (CFR compliance, dial gauge test report)
A
FAT
15
Spare parts list (including spare parts supplier and serial number).
Information content: (1) equipment, equipment functions; (2) drawings or pictures; (3) number and location of spare parts, etc.
The consumable parts must be marked in the spare parts list.
A
FAT
16
Develop maintenance and inspection plans based on supplier location and national standards
A
FAT
17
List of parameters (such as controller, limit)
FAT (SAT review)
18
CE certificate of conformity
A
FAT
19
Program
A
Before SAT
20
IQ and OQ solutions
A
Before SAT
twenty one
SAT report
A
SAT
twenty two
Software CD (SAT version)
A
SAT
twenty three
Zui final completion package (change only)
SAT
twenty four
IQ and OQ reports
A
SAT
25
Noise detection map
A
OQ
26
All functional tests
A
OQ

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