BAGI - MIXER. Magnetically Driven Bottom Mounted Mixers. Sealless ZERO LEAKAGE Design. CIP / SIP Capable. Non Contaminating Mixing

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1 BAGI - MIXER Magnetically Driven Bottom Mounted Mixers Sealless ZERO LEAKAGE Design CIP / SIP Capable Non Contaminating Mixing Completely Drainable Design Mixing Volume from 10L to 20000L

2 Welcome to KWENG MAGNETIC DRIVES M/s. KwenG Alloys Private Limited, located at Bilimora, Gujarath, INDIA is a progressive technically based Company and has 50 people engaged in the Design & Manufacture of Sealless Magnetic Drive Equipments. KWENG - STRENGTH The Company is growing rapidly based upon product quality backed by a design and R&D Team actively engaged in ensuring that Kweng keeps to the forefront of Magnetic Drive Technology. Clients requirement & our experiences from critical applications forms the basic guideline for designing & providing the best solution for the application. KWENG - VISION KWENG s vision for the future growth is based upon a simple idea of indigenously make available all kind of Applied Magnetic Drive Products which are cost effective and complies with international quality standards & services. KWENG - CLIENT RELATIONSHIP KWENG with its wide experience in the development of Magnetic Drives Products and knowledge of the processing requirements of the components for aseptic applications provides a platform for a long term partnership which is handy in meeting the NEEDS of the Client. KWENG will guide and help in developing the best designed equipment ensuring the aseptic process requirement with maximum cost effectiveness. KWENG - QUALITY CONTROL KWENG are holders of Quality Assurance Standard - ISO 9001 : The QA Department at Kweng guarantees full Quality Control & traceability of all its components and during the manufacturing process. The Mixers are CE Certified confirming to International manufacturing practices. QMS 010 DIN EN ISO 9001:2000 Certificate:

The Magnetic Drive MIXING TECHNOLOGY - Final Solution A Magnetic Drive works on the principle of non-contact transmission of torque this same principle has been adopted for the Magnetic Drive Bottom

3 The Magnetic Drive MIXING TECHNOLOGY - Final Solution A Magnetic Drive works on the principle of non-contact transmission of torque this same principle has been adopted for the Magnetic Drive Bottom Mounted Mixers. A Magnetic Drive Bottom Mounted Mixer has many advantages when compared to the conventional top mounted shaft driven mixers considering the aseptic & sterile process applications. Centre Shaft Silicon Carbide Bush Bearing Bush Holder BASIC CONCEPT OF A MAGNETIC DRIVE Isolation Shell/Shroud Driven Magnet Driver Magnet The biggest advantage of the magnetic drive is that it will enable the total integrity of the vessel. As the torque is transmitted contact less there is no physical connection between the Impeller & the Driver, resulting in a ZERO LEAKAGE system, thereby eliminating the question Vessel Sterility and its contents. The other advantage is in the ease of dismantling and serviceability of the Magnetic Drive Bottom Mounted Mixers when compared to top-driven mixers. We often require a mechanical device to dismantle and remove a top-driven mixer from the vessel. Also in some cases there is an elimination of the complex Seals & Seal support systems that need constant monitoring. Another advantage is that of operation even when the vessel is almost empty as the mixer is mounted almost flush to the bottom of the vessel. CIP / SIP Capable The Magnetic Drive Bottom Mounted Mixers BAGI manufactured by KWENG are designed for liquid mixing and complies with the most stringent cleanability and sterilizability requirements. One of the major advantage of BAGI Mixers is that they are totally cleanable and sterilizable in place (CIP/SIP) Cleaning Procedure CIP - procedures can be performed in several different ways depending on various conditions prescribed by the actual application and specific processing conditions. Two main methods can be identified, A and B: A. CLEANING OF THE VESSEL ONLY In this case the vessel will normally be cleaned by washing and rinsing solutions that are sprayed into the vessel through a spray ball located inside the vessel.

4 The bottom outlet valve is in this case left open for the washing and rinsing solution to be continuously drained to a sink. If the spray ball is covering all the surfaces including the Mixing Head this will due to its open structure be cleaned in the same manner as the inner surfaces of the vessel. If the spray ball is only covering the upper pan and the side walls of the vessel: Close the bottom outlet valve. Fill up the vessel with washing or rinsing solution until the Mixing Head is completely covered. Run the Mixing Head at approx. 100 r/m for 10 min. Drain the vessel. Repeat until the equipment is adequately cleaned according to your residuals requirement. (Normally 1 washing + 2 rinsing sequences) B. CLEANING OF THE VESSEL TOGETHER WITH DOWNSTREAM EQUIPMENT, PUMPS, PIPES, VALVES ETC. BY RE-CIRCULATION In this case, when pumps are involved, the vessel must keep a certain liquid volume to feed the pumps. This liquid volume should also cover the Mixing Head. Proceed as follows: Close the bottom outlet valve. Fill up the vessel through the spray ball to cover the Mixing Head + the dead volume in the external piping etc. Run the mixer at approx. 100 r/m. Start the circulation pump, open the bottom outlet valve and let it run according to your standard procedures. Repeat until the equipment is adequately cleaned according to your residuals requirement. (Normally 1 washing + 2 rinsing sequences). So the vessel will normally be cleaned by washing and rinsing solutions that are sprayed into the vessel through a spray ball located inside the vessel.

Design KWENG BAGI Mixers are designed and engineered so as to offer optimum performance, reliability, durability and ease of maintenance.

Some important features for the different parts of KWENG BAGI Mixers as listed as below: Impeller Magnet The Impeller Magnet of the BAGI Mixers sports an open structure so all the surfaces which are

The Impeller Magnets are designed to operate in aseptic processes and are thus designed with no sharp edges, cavities and hidden areas.

Male Bearing The Male Bearing of BAGI Mixers is a single piece fixed to the Weld Plate with the help of proper gasket.

5 Design KWENG BAGI Mixers are designed and engineered so as to offer optimum performance, reliability, durability and ease of maintenance. The design & development of every component is carried out keeping in mind the Aseptic processes for which the Mixers are to be used. Some important features for the different parts of KWENG BAGI Mixers as listed as below: Impeller Magnet The Impeller Magnet of the BAGI Mixers sports an open structure so all the surfaces which are in contact with the product gets easily drained and cleaned in place. The Impeller Magnets are designed to operate in aseptic processes and are thus designed with no sharp edges, cavities and hidden areas. The Impeller Magnet is polished to a high degree of smoothness resulting in complete drainability. Male Bearing The Male Bearing of BAGI Mixers is a single piece fixed to the Weld Plate with the help of proper gasket. The bearing material is Sintered Silicon Carbide (SSiC) fixed on a Stainless Steel support by heat shrinking process. Weld Plate The Weld Plate is welded to the vessel bottom forming an integral part of the vessel and acts as a barrier between the Impeller Magnet & the Drive Unit resulting in contact less transmission of torque. The Weld plate is made SS 316L material machined from a single uniform piece. Drive Unit The Drive Unit consists of Driver Magnet, Gearbox & Motor. As the gear-motor is at an angle it reduces the space requirement at the bottom of the vessel and is also convinent for the operator. The Drive unit is supplied with Clamp Design & bayonet connection for easy assembly & disassembly. For Jacketed Vessels an extended gear-motor is available.

BAGI Mixer - Production & Quality Control KWENG BAGI Mixers are designed & manufactured in accordance with the GMP requirements for CIP/SIP hence, care regarding the Quality of the same is of

Procedures: Keeping into account the various quality standards according to ASME, ASTM specifications care is taken for the need of different quality and material certificates while ordering the

6 BAGI Mixer - Production & Quality Control KWENG BAGI Mixers are designed & manufactured in accordance with the GMP requirements for CIP/SIP hence, care regarding the Quality of the same is of eminence. Procedures: Keeping into account the various quality standards according to ASME, ASTM specifications care is taken for the need of different quality and material certificates while ordering the Stainless Steel. Also it is a practice at KWENG to carry out an independent Material Test once the ordered Stainless Steel is received. Important Checkpoints The KWENG Quality Control program include many checkpoints to ensure that the products comply with the high quality standards that are specified and required. The first checkpoint involves visual inspection of the material to identify the batch and serial numbers and to ensure the quantity correspondence with that of the work order received an d that there is no deviation in it. The second checkpoint involves in process inspection of the material being processed resulting in rejection free production. For the bearing assembly the parts are measured to ensure that they are within the stated tolerances. Dye penetration test is carried out to ensure that there are no cavities between the bearing material & stainless steel. After necessary visual inspection the Mixer parts are marked with individual serial numbers. A dimensional inspection is carried out for the important measurements against the corresponding drawings. The surface fitness is measured to ensure that the Ra value is to the order i.e. Ra < 0.5 µm or better. Each Drive Unit is tested before delivery. After necessary inspection and data filling of individual parts in the prescribed document for internal records will the material be released by the QA Department for delivery. The QA Department also issues the necessary certificates pertaining to the product fulfilling the QA criteria. The Mixer is delivered together with the following documentation: Mixer Documentation File User Manual Material Test Certificates Pressure Test Certificates Warranty Certificates etc.

Applications from Gentle Blending to Vigorous Mixing KWENG BAGI MIXER APPLICATIONS KWENG BAGI Mixers are primarily designed for general aseptic processes.

The Mixers are considered & chosen for a wide area of applications in different type of processes for medium viscosity liquids.

7 Applications from Gentle Blending to Vigorous Mixing KWENG BAGI MIXER APPLICATIONS KWENG BAGI Mixers are primarily designed for general aseptic processes. Considering the application area the Mixers are designed for gentle blending or vigorous mixing of the liquid products. The Mixers are considered & chosen for a wide area of applications in different type of processes for medium viscosity liquids. KWENG also designs customized Mixers for their clients which can fulfill their SPECIAL OPERATION condition in addition to the general purpose Mixers especially for higher viscosity liquids. The BAGI Mixers can also be supplied in different Material of Construction like SS 316L, Hastealloy, Titanium etc. KWENG - CUSTOM SOLUTIONS KWENG BAGI Mixers are designed for aseptic mixing processes. KWENG are capable of providing custom designed mixers as per the requirement of the clients. Some of them are listed below: 1. Bottom Mixers with CENTRE MOUNTING Design with Multiple IMPELLERS 2. Bottom Mounted High Shear Mixers 3. Mixers for Dual Mixing requirements 4. Top Mounted Mixers & Agitators SOME APPLICATIONS KWENG BAGI Mixers are designed for gentle blending to vigorous mixing of liquid products within the aseptic mixing process such as Injectables, Vaccines, Infusion Solutions, Plasma Fractions, Bacteria and Cell Cultures and different types of Suspensions. The most common application is Gentle Blending such as for keeping the suspensions well distributed in the liquid, dissolving solids in to liquids, temperature regulation. Some applications are as listed below: A. Cell Cultures B. Fermenters C. Plasma Fractions D. Dairy Applications E. Syrups For KWENG to design or suggest a right Mixer for a specific application different parameters like Vessel Capacity, Size of Vessel, Type of Vessel, Liquid properties, Type of Mixing required has to be provided.

Other Kweng Products KWENG with presence in all the sectors of the

clients require a partner for their success rather than a good

Hence, Kweng has invested a great deal of their effort, time and

supplying equipments for Aseptic & High Purity Processes, Bulk Drug

KWENG PRODUCT RANGE BAGI Mixers Magnetic Drive Bottom Mounted Mixers

Inline Homogenizers Pumps Pressure Reactor System Magnetic Drive

Homogenizers Top Mounted Magnetic Agitator Drives - Process Scale

Homogenizers Magnetic Drive Pumps Pressure Reactors with Magnetic

8 Other Kweng Products KWENG with presence in all the sectors of the Pharmaceutical, Bulk Drug & Chemical has learned that most of the clients require a partner for their success rather than a good supplier. Hence, Kweng has invested a great deal of their effort, time and experience to be a partner in the endeavors of its clients by supplying equipments for Aseptic & High Purity Processes, Bulk Drug Processes, Chemical & petrochemical processes. KWENG PRODUCT RANGE BAGI Mixers Magnetic Drive Bottom Mounted Mixers BAGI Mixers (CM) BAGI Homogenizers MDTA Agitator Drives MDLA Mixers Inline Homogenizers Pumps Pressure Reactor System Magnetic Drive Bottom Centre Mounted Mixers Magnetic Drive Bottom Mounted Homogenizers Top Mounted Magnetic Agitator Drives - Process Scale Magnetic Drive Mixers for Lab Reactors Magnetic Drive In Line Homogenizers Magnetic Drive Pumps Pressure Reactors with Magnetic Mixers KWENG ALLOYS PRIVATE LIMITED J - 66, G.I.D.C., Antalia , Bilimora, Gujarath, INDIA Tel.: (91) - (2634) Fax: (91) - (2634) kwengalloys@yahoo.com DS BAGI

ZETA MAGNETIC AGITATORS

ZETA MAGNETIC AGITATORS For sterile liquid processing www.zeta.com ZETA AGITATORS A VERSATILE PRODUCT FAMILY Proven agitator technology that meets the highest standards of sterile design and reliability.