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Pure Steam Generator
The Pure Steam
Generator is used to produce Pyrogen/ Endotoxin free Sterile Steam. The Pure
Steam Generator (PSG) utilizes a falling-film type evaporator which produces
pyrogen free pure steam, using a unique separation technology. Feed water is
continuously pumped to the top of the evaporator heat exchanger, heated by
plant steam. Upon reaching the bottom of the column, the evaporated part of the
feed water continues vertically up the riser space of the column and around
spiral shaped guides. These spiral guides induce a centrifugal action of the
steam to remove any remaining microscopic droplets that contain impurities
and/or pyrogenic material. The separated droplets are then removed as blowdown.
Why STERINOX’s Pure Steam Generators?
· Cost Savings –Efficient column design helps lower energy and utility consumption.
· Highest Pure Steam Quality –Three stage pyrogen separation and continuous blowdown removal.
· Productivity – Tight pressure control and quick response time shortens sterilization cycles.
· Easy to Validate – Units are fully tested and pre-validated to customer specifications during factory qualification.
· Automation – Latest PLC based 21 CFR Part 11 complied fully automatic Control.
· Wide Range – 50 KG/Hr to 3000 KG/Hr
· Constructional Features – 1) All Heat Exchanger tubes will be Seamless quality.
2) Double Tube Sheet Construction of Column where Boiler Steam is Present.
3) Manufactured as per ASME BPE and cGMP Guidelines.
2017On CPhI since
- Supplied fromIndia
2017On CPhI since
More Products from Sterinox Systems
We are among the top most organization in offering a premium quality range of PW/WFI Storage Tank to our clients. We are the prominent manufacturer and supplier of these quality range. Our products are widely demanded and appreciated by our premium clients. These products are available at market leading price.
· All storage tanks comply with ASME (BPE) and ASME section VIII, Div 1 guidelines and manufactured as per cGMP guidelines
· Single / dual jacketed and limpet tanks are provided with suitable insulation and AISI 304 stainless steel cladding
· Option of Industrial steam (bolter steam), electrical immersion heaters / ceramic band heaters
· All contact parts are made of AISI 316L stainless steel and non-contact parts are made of AISI 304 stainless steel
· All wetted surfaces are internally electro-polished to 0.4 Ra or less
· The capacity vanes from 100 lit. to 20,000 lit.Sterinox offers its customers various possibilities for the integration and execution of PW and WFI water generation, storage and distribution projects or pure steam networks under the “turnkey” modality.
Distribution skids are perfectly designed for the production of purified water or water for injections (WFI) depending on a case by case basis. The design of the skid will be adapted to the peak demand, the isometrics of the piping system, the number of points of use, current or future needs, etc.
For the design and construction of the entire plant, all the necessary pharmaceutical guides for validation and applicable technical standards are followed (GMPs, USP, DIN EP, ASME, ISPE, etc.).
Cleaning-In-Place (CIP) and Sterilization-In-Place (SIP) are systems designed for automatic cleaning and disinfecting without major disassembly and assembly work. We design, develop, manufacture, supply and install Mobile and Fixed CIP & SIP Units for sanitization and sterilization. The units are custom made, modular, skidded in automated or semi-automated Models as per the required time cycle for cleaning and sterilization as a part of cGMP requirements from portable to large fixed Multi-Tank system.
- Sanitary Design to meet all cGMP criteria.
- Contact parts : SS 316 L, Mirror polished & EP to < 0.5 Micron finish
- All Non- Contact parts : SS 304 Matt finish
- Orbital Tube welding
- Automation as per MCA & USFDA 21 CFR Part 11Built to custom requirement
- 100% Drianability
- GMP documentation like DQ, FAT, IQ, OQ & PQ Protocols
- Site Installation & Commissioning
- Documented Output of cleaning & sterilization cycles
Oral liquid manufacturing plant comprises of sugar syrup vessel, online sugar syrup pre-filter, manufacturing vessel storage vessel, vacuum system for transfer of sugar and sugar syrup, product piping, control panels and transfer pumps. The construction of the complete system is done in a way that allows for plant to be easily handled by single operator, thus saving on man- power costs. The system provides option of boiler steam heating / electrical heating to achieve and maintain the desired temperature.
Ø Oral Liquid Manufacturing Plant is manufactured under GMP guidelines.
Ø The design of the plant is tailor-made.
Ø All the contact parts are made of AISI 316L stainless steel.
Ø Crevice & Dead leg free design, Contact surfaces to less than 0.5 from inside.
Ø Complete drain ability.
Ø Product Sampling devices.
Ø Food Grade Gaskets in compliance with FDA.
Ø Zero Dead-Leg Flush Bottom Diaphragm Valves.
Ø Load cells with control unit for the main manufacturing vessel.
Ø PLC based panel with touch screen HMI and menu options for the panel.
· Food Industry
· Pharmaceutical Industry
· Confectionery industry
Multi Column Distillation plant ( Water for Injection Generation Plant) produces low conductivity pyrogen / endotoxin free Water For Injection (WFI) by stage distillation process. Our Plant is based on falling Film Evaporator Technology.
- Capacity varies from 5 to 6,000 litres per hour
- Designed and manufactured as per ASME BPE and cGMP guidelines
- WFI generated meets USP, EP, BP and IP standards
- Specially designed and constructed to remove pyrogen / endotoxin
- All heat exchange tubes will be seamless quality and Double Tube Sheet Construction provided wherever boiler steam is present
- Designed and constructed to achieve 100% drainability
- PLC based CFR21 part 11 complied fully automatic control panel with online printing facility
- Complete set of documentation and certificates to ensure compliance with regulatory authority. We provide DQ, OQ, IQ, FAT & SAT. Also assist client to develop PQ
Purified Water (PW) Treatment Plants (RO-EDI Plants) generates High Purity water for pharmaceutical, Biotech, Semiconductor and ‘Food & Beverages Industry.
Sterinox Purified Water Treatment plants are designed and optimised for hassle free low maintenance operation. The entire system utilises best instruments and equipments ensuring solid performance and reliability. Sterinox Purified Water Treatment Plants are skid based and designed to accommodate in minimum footprint.
· The final output quality complies with USFDA, MHRA, WHO, EU 8L other international pharmacopeia's and standards Plants are manufactured as per cGMP guidelines and complies with ASME BPE Standard.
· PLC based fully automated plant complies with 21 CFR Part 11 8t GAMP 5. Hence low maintenance and minimum human interference required.
· Designed for minimum dead leg criterion of < 1.5 D. Also 100% drainability can be achieved by maintaining the minimum slope of 1:100
· Complete inter connecting piping is semi seamless tubes as per ASTM A270.
· All contact parts are AISI 316L Stainless Steel and Non-Contact parts are A151 304 Stainless Steel.
· All contact parts surface is electro polished to less than 0.4 Ra surface finish, All interconnecting piping are orbital welded using High Purity (99.99%) argon gas and welding joints can be inspected by boroscopy machine.
· Complete set of documentation and certificates to ensure compliance with regulatory authority. We provide DQ, OQ, IQ, FAT 81 SAT. Also assist client to develop PQ.
Sterile Solution Manufacturing vessels are required to manufacture liquid injectable products. We adhere to stringent manufacturing processes and follow cGMP / ASME BPE guidelines to manufacture the Sterile Vessels. Manufacturing and Holding Vessels are accompanied with suitable high grade filtration to get the final product. The Vessels are desrgned to achieve online CIP and SIP. Sterile vessels are provided with necessary accessories, high grade instruments and PLC based control panel to monitor and control the process of manufacturing to utmost integrity.
Ø Zero dead leg aseptic design of bottom outlet valve
Ø Zero dead leg aseptic design of sampling valve
Ø Calibrated full view glass forthe blending vessel
Ø Volume monitoring by load cells
Ø Process Automation
Ø Operation: Fully Automatic with PLC & HMI/ SCADA system
Ø Steri connection and flanges to avoid product contamination
Ø Inbuilt CIP-SIP Provided
Ø Agitator: Bottom driven agitator (Electrical 81. Magnetic)
Ø Functionally : Cleaning in place, Sterilization in place, Fermentation process with temperature control, pH control, DO control
Ø Jacket with Pressure gauge, Safety Valve, Vent, Chilled water supply 8t return, Drain, Circulation pump with heat exchangers for fine temperature control
Ø Spray bail, pressure gauge, foam sensor, pH sensor, Temperature sensor, vent Line, ZDL Bottom outlet port, ZDL Sampling port, Sanitary safety relief valve
Ø Valve, Acid / Alkali / feed addition lines with sterile four way valve, peristaltic pump, media filter (NFF type)
Ø Incinerator after exhaust filter
Ø Sterile Solution
Ø Large Volume Parenterals
Ø Small Volume Parentetals
Ø IV Fluids
Ø Oncology Products
Sterinox Systems resources
We introduce our company M/s Sterinox Systems as one of the leading pharmaceutical machinery manufacturers in India. We are a technology driven quality conscious engineering organization.
We are into the designing & manufacturing of pharmaceutical machineries. We have a range of machineries and equipments for injectable, liquid & ointment sections. Given below is a list of machines, equipments / Plants being manufactured by us.
Also Please find attached our company brochure for furthermore information on our products.
By implementing benchmarking technologies in manufacturing process and setting up fully-equipped in house quality, we are committed to international standards, We at Sterinox, ensure the high Quality products for our customers. We manufacture as per cGMP (current Good Manufacturing Practice) and adhere to our quality standards stringently. We have a QAP (Quality Assurance Plan) in place. This helps us to match the client expectations worldwide.
Our products comply with ASME (BPE), ASME Section VIII Div 1, US FDA, EP, BP, IP and USP design standards. Our equipments also comply with 21 CFR Part 11 & GAMP 5.
Our association with Pharma Industry is more than 15 years old now. We are located in Mumbai, India. It is our design & engineering Centre. A team of well qualified engineers and draughtsmen carry the responsibility to deliver the best quality to our esteemed clients. Our manufacturing plant is less than an hour away from Mumbai. It is a hub of qualified production & quality management team backed by skilled workers and latest machineries. Over the years we have developed efficient manufacturing techniques which allow us to stay afloat in cut throat competition. We believe in continuous improvement.
Currently we are working with many reputed clients. Some of them are Alkem Laboratories, Acme, BDH Industies, Amneal Pharmaceuticals, Synmedic Laboratories, BION Healthcare, Himedia Laboratories, Finecure Pharmaceuticals, TEVA Pharma & Mankind Pharmaceuticals etc.
We have exported across the globe. Some of the major countries we have exported our products to are Sudan, South Africa, Lesotho, Morocco, Bangladesh, Kazakhstan, Uzbekistan, Peru, Moldova & Australia.
With reference to TradeIndia enquiry, we kindly ask you to share Exact Capacity of Ointment Manufacturing Plant to enable us to submit our best Techno-commercial offer.
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