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www.san p ure. inA n I S O 9 0 0 1 : 2 0 1 5 C e r t i f i e d C o m p a n y

About usFounded in the 2012, Sanpure was born out of a vision to create a company that can deliver value engineered high purity water systems to the pharmaceuticals and bio-pharmaceuticals.

Sanpure is the brainchild of Basavaraj Nekar, a chemical engineer and a project manager with over 23 years of experience in project execution, design and engineering of pharmaceutical water systems.

Our systems are different, never generic, always customized and optimized to suit our client requirements. Our system designers keenly focus on the design that deliverys the highest lifecycle value. All our systems are designed with high reliability coupled with low cost of ownership.

driven by performance and passionWe are driven by our passion for water treatment. All Our water systems are designed to perform and operate reliably and optimally for a longer period of time with the lowest cost of operation. Experience gained by our designers over the years have seen our water systems evolve to be more operator friendly, with low operational cost and with high performance efficiency. A fact that is proven by studying the various systems installed at our customer’s site.

Our mission

To design, engineer, install and support state-of-art high purity water systems that are smart and efficient and yet with low cost of ownership.

Our vision

To be the most trusted and preferred vendor to our customers and employer to our employees.

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our infrastructure

We are headquartered in the 400 years old historical city of Hyderabad in deccan plateau, south of India. Last year we shifted to a new, fully integrated design, engineering and manufacturing facility at the industrial estate at Jeedimetla in Hyderabad. The fully integrated facility is a centre of all our departments and houses, the following departments:

DESIGN, PLANNING & ENGINEERING

An ideal place for creative engineers and an ideal environment to brainstorm new possibilities and creative optimization methods. An ideal place where value engineering is valued highly.

FACTORY ACCEPTANCE TESTING (FAT)

A dedicated area to conduct Factory Acceptance Testing with all utilities and testing infrastructure in place.

MATERIAL TESTING LABORATORY

Equipped with the latest material testing instruments, this is an integral part of our quality assurance and control departments. All outsourced materials and components like tubes, fittings, etc. received from our partners are tested for material consistency and composition.

QUALITY CONTROL LABORATORY

Quality is paramount at Sanpure. We have laboratory fully equipped with all the requisite testing and measuring instruments that are well calibrated. Our trained and experienced quality control team ensures stringent quality checks before any equipment is shipped out.

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our core competencies

design & engineering fabrication, assembly & testing installation & commissioning validation support

We have a team of highly experienced design engineers, committed and passionate. We strive to ensure all our water systems are designed to deliver quality with low operational costs. We like to call it as value engineering as this ensures our systems are designed with low cost of ownership. Our designers also spend time as service engineers to ensure better understanding and strive to constantly improve on the design for optimized performance.

A fully equipped fabrication shop with highly trained welders, fitters and technicians deliver their expertise during the fabrication and system assembly. The assembled systems undergo stringent testing to ensure integrity and quality of the fabrication and assembly. Tests like radiography, borescopy, surface analysis, pressure and vacuum tests are conducted to ensure utmost safety and performance.

Proper planning, experience, training and expertise is critical to foresee, prevent or respond to challenges that might come up at the site during the installation and commissioning phase. Our highly experienced and expert installation and commissioning team works dedicatedly to ensure smooth system installation and commissioning at the site. Our quality team at the site ensures the system is installed and commissioned as per the documented standards.

We understand very well that system validation is very critical to the pharmaceutical industry. Our highly experienced quality control team delivers full support in this regard. All relevant documents like test certificates, calibration certificates, material test report etc., are delivered in well organized folders. The team also ensures support to our customers in validating our system as per the required DQ, IQ and OQ protocols.

potable water generation system purified water generation system storage & distribution system

A good and robust pre-treatment system and potable water generation system is the foundation for an efficiently performing purified water system. We design and deliver robust pre-treatment system that can consist of ClO2 dosing, Multigrade sand filters, Duplex short cycle regeneration softeners, Ultrafiltration system, pH correction systems, dechlorination system etc.

Our Purified Water Generation system performs efficiently to deliver consistent design parameters. Since all the fluctuations are taken care of in the pre-treatment stage, the Purified Water Generation system works smoothly and efficiently. Our product range includes hot water sanitizable sanitary RO-EDI, RO-EDI-UF systems with automation that is easily controlled by intuitive touch screen HMI.

Our specialization in designing Storage & Distribution system has been well established. Our distribution, disinfection and monitoring systems are robustly designed with built-in safety and alarms. This ensures quality of purified water at the user points. Our system can be sterilized with clean steam and sanitized with hot water or Ozone. They are PLC / SCADA driven and easily controlled by intuitive touch screen HMI.

our products

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HOLLOW FIBER UF SYSTEM | SANITARY RO SYSTEM ( HOT WATER SANITIZABLE ) ELECTROLYTIC OZONATION SYSTEM, TOC UV SYSTEM sanitary ro-edi system, UF SystemCLO2

DOSING SYSTEM | O3 GENERATORS | SAND FILTERS | DUPLEX SOFTENERS

disinfection, PRE-TREATMENTSYSTEM

potable water purified water

ULTRAFILTRATION SYSTEM, SANITARY RO SYSTEM

RO-EDI SYSTEM,ro-edi-Uf system

generation systems

POTABLE WATER GENERATION SYSTEMS

A good and robust pre-treatment system and potable water generation system is the foundation for an efficiently performing purified water system. We design and deliver robust pre-treatment system that helps deliver quality Purified Water consistently. Our products include;

• ClO2 / NaOCl dosing system• Ozonation system• Multigrade sand filters with auto backwash cycles• Duplex short cycle regeneration softeners• Ultrafiltration system with fully automated backwash• pH correction• Dechlorination system

PURIFIED WATER GENERATION SYSTEM

We specialize in the design of high end Purified Water Systems that deliver water quality far above the acceptable USP Purified Water standards. Our product range include;

• Sanitary RO-EDI systems with features like;

• Fully automated hot water sanitization

• PLC based controls with intuitive touch screen MMI

• Online parameter monitoring and data logging

• Compact and skid mounted

• High quality Instruments and valves

• High end features like permeate rinsing and flushing

• Automated safety features and alarm

It is necessary to design a Purified Water System that far exceeds the qualitative requirements at the point of use. This is to compensate for the natural degradation, like the increase in conductivity during storage and distribution. Our systems are designed to far exceed the minimum quality specifications of the USP. Ease of operation and sanitization are also critical to quality. Our systems also enable continuous monitoring of all critical parameters like conductivity, temperature, TOC, Pressure, Velocity etc., and enable continuous data logging of these parameters.

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pfw / wfi systems

storage & distribution disinfection ( uv / ozone ) monitoring skid control panel ( plc / scada )

Efficient design of storage and distribution is critical to quality as well as to the operational cost. Our integrated storage and distribution systems include;• Storage Tanks ( Jacketed, insulated )• Distribution pumps ( Sanitary, Centrifugal )• UV systems ( 254 nm )• Distribution loop piping • Sanitary spray ball• Compact skid mounted systems

Our systems ensure that the microbial limits are always under control. Our systems come with the following methods of disinfection;• 1. UV Systems ( @ 254 nm with continuous intensity monitoring )• 2. Ozonation systems( Electrolytically generated from Purified Water )• 3. Clean steam sterilization systems

We design systems compliant with standards such as ASME-BPE. All our systems are designed with continuous online monitoring capability like;• Conductivity• Flow / Velocity• Pressure, pH• Temperature• TOC

Our highly experienced design engineers understand the need for a easy to use, intuitive and easy to operate, monitoring and control systems is critical to the system performance. Our systems come with the options of;• PLC controls ( with large touch screen mimic HMI )• SCADA controls( In compliance with 21 CFR Part 11, GAMP )

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borescopy , radiography HYDROTEST AND PASSIVATIONORBITAL WELDINGERECTION & FITMENT

purified water wfi clean steam process sterile air n2 / o

2 gas

distribution pipingDesign of a good distribution system for critical fluids like Purified Water, Water for Injection, Clean steam, Sterile air, Nitrogen etc., is very critical to deliver the high quality of fluid generated at the generation source. The fluid has to be distributed to the user points, long distances, with nil or minimal degradation of quality. The key factors that affect the distribution system are;

• Design

• Material of construction

• Surface finish (SF4)

• Installation

• Drainability

• Dead leg elimination

We design, engineer, supply and install pipings that conform with standards like

• ASTM A 270

• ASME-BPE

We have good expertise, understanding and experience in designing and installation of distribution system with ASME-BPE specifications for critical Bio-processing applications. We have specially trained and experienced orbital welding technicians who ensure strict adherence to the ASME-BPE guidelines. We have specialized and highly trained site crew who ensure proper installation. Our quality control supervisors ensure the installation at the site matches the design and the regulatory requirements. We ensure proper documentation of critical parameters at site and generate to monitor welding (weld reports) installation slopes (Slope report), weld and joint integrity (Pressure test reports), Dead leg free installation (drainability reports) etc., that help in the system validation.

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OUR EXPERIENCE AND EXPERTISE COMES WITH YOU

When you work with us, you have the backing of a very strong project management team with years of experience and expertise behind them. Right from the time we receive your order till the day we handover the systems our capable project leaders work to ensure alignment with your project goals and expectations. Our project team leverages on years of expertise and wisdom to deliver a project with endearing value.

WE WORK TOGETHER WITH YOU

Our project team closely interacts your team throughout the entire project lifecycle and assist you for the qualification and validation of the systems. The goal is to ensure the shortest project Turn Around Time (TAT).

QUALITY ASSURED AT THE PROPOSAL STAGE

A pharmaceutical water system contains many bought out components that are very critical to its functionality like the RO membranes, all the critical monitoring and control instrumentations, the pump, EDI module, Ultrafiltration membranes etc. Our design team works hard to evaluate these critical components for its quality. Many of them are sourced from some of the leading companies in the world. We study and evaluate these products and their performance. Only after we assure ourselves of the products durability, performance, consistency and quality, we include them in our proposal to you.

QUALITY ASSURED AT THE MANUFACTURING LEVEL

Our quality assurance team ensures and enforces strict adherence of the quality policies laid out for the manufactured and assembled

components at our factory. We also have a team of qualified and trained engineers to monitor quality of fabricated items that are subcontracted to some of our highly experienced, pre-evaluated and qualified vending partners.

QUALITY AT THE DOCUMENTATION LEVEL

Validation is critical to the pharmaceutical industry. Our quality team ensures all the key components that goes into our water systems are traceable with proper traceability documents. They also ensure collection and generation of all critical documents like weld reports, material analysis reports, calibration certificates, pressure test reports etc., are submitted to your validation team for the validation purposes. Our quality engineers work very closely with you during the Installation Qualification ( IQ ) and Operational Qualification ( OQ ) stages.

PROJECT MANAGEMENT quality & DOCUMENTATION

PLANNING AND EXPERIENCE

We begin by allocating a project lead for every project ensuring that there is a single point responsibility to ensure speedy responses. The process begins with the creation and approval of P&ID drawings. This initiates the whole process of procurement, manufacturing and then assembly. A typical project sequence for the Purified Water Generation, Storage & Distribution could be;

1. Order

2. P&ID approval

3. Detail engineering

4. DQ approval

5. Procurement

6. Manufacturing

DISTRIBUTION PIPING PROJECT MANAGEMENT

Our experienced piping engineers ensure translation of the piping plan, routing into field erection. Qualified and certified welder are deputed for critical orbital welding procedures. Our site quality engineers ensure adherence to our piping protocols that provided guidelines like minimum pipe support distances, minimum acceptable orbital weld quality, pipe distances and other procedures. Every site throws its own challenges but the experience of our site crew ensures that these do not derail the delivery schedule or the accepted quality of the erection.

DOCUMENTATION SUPPORT

The team leader at the site is responsible for generating all the documents related to site activities. Our quality team closely co-ordinates with the site team leader to ensure compilation of all critical reports like welding reports, pressure test report, passivation report, drainability test report, as built isometric drawings etc.

7. Assembly

8. Internal quality Testing

9. FAT

10. Installation (SAT)

11. Commissioning (OQ)

12. Project handover

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s a n p u r e s y s t e m s p v t. lt d .

www.sanpure. in

SANPURE SYSTEMS PVT LTDPlot No. 78, Sy. No. 285 to 288, KK Owners Society,IDA Jeedimetla, Phase V Extn., Qutubullapur, Hyderabad-500055, Telangana.info@sanpure.inwww.sanpure.in

040-40213887 / 40188797

SELECTED REFERENCES

SHANTHA BIOTECHNICS LTD

KARNATAKA ANTIBIOTECHNICS PHARMACEUTICALS LTD

SANVITA BIO TECHNOLOGIES PVT LTDNEULAND LABORATORIES LTD

AGILA SPECILTIES PVT LTD

NOSCH LABS PVT LTD

KNEXIR CONSULTANTS PVT LTD

EPR CENTRE FOR CANCER RESEARCH & BIOINFOMRATICS PVT LTD

ESCIENTIA ADVANCED SCIENCES PVT LTD

PIRAMAL ENTERPRISES LTD

STRIDES SHASUN LTD

LANTECH PHARMACEUTICALS LTD

VIRCHOW BIOTECH PVT LTD

JACOBS ENGINEERING PVT LTD

INDIAN IMMUNOLOGICALS LTD HEMARUS THERAPEUTICS LTD

JUBILANT GENERICS LTD

IPS MEHTALIA PVT LTD

CAPLIN POINT LABORATORIES LTD

SUVEN LIFE SCIENCES LTD

GRANULES INDIA LTD

KEKULE LIFE SCEINCES LTD SP ACCURE LABS PVT LTD

HETERO GROUPS

GLAND PHARMA LTD

JODAS EXPOIM PVT LTD

ASPIRO PHARMA LTD

SPECTRUM PHARMATECHCON

SULT

ANTS

INOGENT LABORATORIES PVT LTD

NATCO PHARMA LTD

MYLAN LABORATORIES LTD

BIOLOGICAL E LTD

VIVIMED LABS LIMITED EISAI PHARMACEUTICALS INDIA PVT LTDLAURUS LABS LTD

ANNORA PHARMA PVT. LTD

SRIAM LABS PVT LTD

SHILPA MEDICARE LTDDIVIS LABORATORIES LTD

DR. REDDY’S LABORATORIES LTD

SYNGENE INTERNATIONAL LTD SERUM INSTITUTE OF INDIA PVT LTD

BIOCON LIMITED

A n I S O 9 0 0 1 : 2 0 1 5 C e r t i f i e d C o m p a n y

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