Marya GMP Standard Pharmaceutical Sterile Injection Purified Water System Supplier

• Customization: Available
• Certification: CE, GMP
• Salt Rejection Rate: 99.5%
• Model NO.: MY-PW
• Application: Industry
• Capacity: 400 Gallon
• Usage: Pw & Wfi System
• Core Components: RO Systems or EDI Systems
• Material: Stainless Steel
• Qualification Documents: Dq, Iq, Oq, Pq
• After-Sales Service: Field Installation, Commissioning and Training
• Typical Waste Disposal Ratio: 2-8 %
• Gas Pressure Output Range of Pure Steam: 2-5
• Transport Package: Wooden Case Packaging
• Specification: Customized
• Trademark: MARYA
• Origin: China
• Package Size: 2100.00cm * 1200.00cm * 2400.00cm
• Package Gross Weight: 1200.000kg

Product Description

Marya GMP Standard Pharmaceutical Sterile Injection Purified Water System Supplier

Introduction

The pharmaceutical purified water system is a crucial component in the pharmaceutical industry. It is designed to produce and supply high-quality water that meets the stringent purity requirements for various pharmaceutical processes, including drug formulation, manufacturing, and cleaning of equipment.

Pharmaceutical PE Water Tank

Mainly used for the storage of raw water for pharmaceutical water treatment and of medicine liquid for dosing system. 
 

(1)Tough material: mainly made of polyethylene, light and tough, easy to handle, shockproof, impact-resistant;

(2)Good drug resistance: excellently resistant to various acids and alkalis corrosion;

(3)Clean and beautiful: beautiful streamline shape, not easy to be dirty,easy to clean;

(4)Economic and durable: tank body is formed in one piece without bonding, not easy to crack; 

(5)Good heat and freeze resistance:  can be used at 80 to -40ºC; 

(6)Difficult to leak: the outlet nozzle is made of the same material as the tank body, and processed by hot melt method, so the risk of liquid leakage is low;

Stainless Steel Tank

Mainly used for the storage and transport of  liquids in the pharmaceutical, food and chemical industries.
 

(1)A variety of product materials available to adapt to various production environments: 316L, 304, 904L, titanium alloy, super stainless steel, hastelloy, etc.; 

(2)Design and manufacture in accordance with ASME BPE standard specifications, and meet cGMP and FDA requirements; 

(3) Mechanical and electrolytic polishing of inner surface, and Ra can be 0.28 to 0.4μm; 

(4) Internal structure of the jacket is honeycomb or semi-tube, realize heating or cooling; 

(5) Chlorine-free thermal insulation materials, shell welding structure, easy to scrub and clean; 

(6)Can be used in the formulation system, with optional, various and comprehensive accessories, including light mirror, sight glass, hand hole, manhole, weighing and stirring devices, etc. 

Purified water machine 

Based on membrane technology,high efficient and energy-saving pharmaceutical purified water equipment that meets GMP requirements.
 

 (1) Modular design, compact structure, easy and fast field installation;

 (2) Advanced automatic control mode, stable and reliable operation; 

 (3)Double softeners in series or parallel, alternate resin regeneration, and effective control of microorganisms; 

 (4)Full pasteurization, and flexible disinfection methods; 

 (5)Dual water supply and unique circulation mode to prevent breeding bacteria throughout the system; 

 (6)Constant pressure control prevents system pressure from being too high in the circulation state and prolongs EDI service life; 

 (7)The recovery rate of reverse osmosis system can be adjusted automatically, or it can be equipped with concentrated water recovery device, which greatly saves energy;

 (8)Flexible water supply to reduce shutdown time, save energy and improve equipment life;

PW/WFI Storage & Distribution System

Designed with cGMP, ISPE guidelines and FDA specifications for PW/WFI storage and delivery. 
 

(1)PW/WFI modular design with compact structure and easy operation and maintenance; 

(2)Frequency conversion operation of circulating pump, and system flow design and operation in line with GMP and ISPE guidelines; 

(3)Fully automatic control of CIP and SIP of storage and distribution system; 

(4)Design and manufacture the integrated solutions for purified water, water for injection, pure steam, compressed air, nitrogen, etc. that meet the process requirements of pharmaceutical companies; 

(5)The control system can automatically generate electronic reports and records, and has the functions of audit tracking, intelligent maintenance and remote troubleshooting. 

Multi-effect water distiller

Provide a flexible one-stop solution based on distillation (i.e.thermal) to generate the pharmaceutical-grade water for injection (WFI), and mainly used in liquid formulation, biological fermentation, aseptic container cleaning and other applications.
 

(1)Three-stage separation, external spiral structure, falling water  membrane flash evaporation and vapour-liquid separation.

(2)Parts contact with raw water, cooling water, pure steam and distilled water are made of stainless steel 316L, and the sealing is PTFE. 

(3)An incondensable gas emission equipment is installed. 

(4)Pure steam can be produced (optional). 

Pure steam generator 

Provide a flexible one-stop solution based on distillation (i.e. thermal) to generate pharmaceutical-grade pure steam (PS), and mainly used for high temperature sterilization of clean equipment to meet CIP/SIP requirements of equipment. 
 

(1)Rapid response to pure steam capacity requirements, greatly shortening sterilization cycle; 

(2)Accurate pure steam output pressure and temperature control, fluctuation within ±5%; 

(3)Unattended, suitable for the simultaneous use of multiple sterilization points ; 

(4)Typical waste discharge rate: 2-8%; 

(5)Pure steam production pressure output range: 2-5bar; 

(6)Pure steam quality meets the requirements of the content,  and degree of dryness and superheat of  non-condensable gas defined in HTM2010(EN285) standard.