Sterile solution mixer/magnetic mixer
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IV (Intra Venous) / Large Volume Parental (LVP) SOLUTION MIXING SYSTEM
The entire Pharmaceutical industries engaged into the manufacturing of Large Volume Parental primarily relies on Two type of Solution preparation technologies i.e. Magnetic Mixer and High Shear Online Mixer. Now selection of any of these Mixers depends upon stringency of Validation, Batch Standardization protocol, Cleaning Protocol & mainly batch size and typically dissolution of solute into media i.e. WFI. In both the mixer design, adherence of basic design parameters of Injection plant is maintained in totality viz. Mono bloc design, Zero dead pocket vales, SIP (Sterilization In Place) & CIP (Clean In Place) compliance, Surface finish etc. Broadly details of both the mixer design is as below :
MAGENTIC MIXER
Magnetic Mixer has a drive mechanism that can be removed quickly and easily – a major advantage, because small vessels can then be autoclaved rather than sterilized-in place (if preferred). All product contact parts are stainless steel 316L, with special grade tungsten carbide bearing surfaces.
These allow smooth trouble free operation and are an integral part of the impeller head and carrier. The open impeller design allows easy cleaning and can easily be removed for separate cleaning and sterilization. INTERTECH Magnetic Mixers are fully engineered & designed for better CIP/SIP compliances.
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| Note: |
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The mixing capacities above are based on aqueous like products with a density of 1000kg/m3 (S.G.=1) and a viscosity of 1cp.
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Typical applications for 'Gentle' mixing are where solids are held in suspension.
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Typical applications for 'Blending' are where soluble liquids are mixed together or where powders easily dissolve into the liquid.
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Typical applications for 'Vigorous' mixing are where a vortex is required for blending of powders into a liquid.
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Technical Specifications |
| Model Number |
Mixing Capacity
Litres
(Gentle) |
Mixing Capacity
Litres
(Blending) |
Mixing Capacity
Litres
(Vigorous) |
Motor Power Rating |
Impeller Diameter |
Vessel
Pad
Diameter |
| IET 120 |
10 to 40 |
10 to 30 |
10 to 20 |
0.12kW |
95mm |
60mm |
| IET 370 |
50 to 650 |
30 to 500 |
30 to 350 |
0.37kW |
115mm |
88mm |
| IET 750 |
500 to 2500 |
500 to 2000 |
500 to 1500 |
0.75kW |
170mm |
144mm |
| IET 1100 |
2000 to 6000 |
2000 to 5000 |
2000 to 3500 |
1.1kW |
200mm |
165mm |
| IET 1500 |
4000 to 12000 |
4000 to 10000 |
4000 to 7500 |
1.5kW |
240mm |
200mm |
| IET 3000 |
6000 to 25000 |
6000 to 20000 |
6000 to 12000 |
3.0kW |
300mm |
250mm |
It should be noted that higher is the viscosity , lower is mixing capacity of Mixing head. Therefore, selection of
Mixing head is based on media Viscosity & demand of mixing application.
CONSTRUCTION DETAILS:
- Inside the impeller head is a ring of rare earth magnets encapsulated in a 316L stainless steel housing. Welded to this housing are the mixing blades, which form an integral impeller head.
- The blade shape and profile has been determined to optimize agitation levels and to direct a proportion of the cleaning fluid through the head.
- A drive unit mounts externally to the vessel and can be quickly and easily removed using a bayonet type connection. This is particularly useful when sterilizing the vessel in an autoclave or when sharing a single drive unit between vessels.
- The impeller head runs on a special grade of tungsten carbide that has been manufactured under controlled conditions to achieve the correct size, grain structure and hardness. The running surfaces have a ground mirror finish.
- The vessel can be cleaned in place (CIP) using spray balls and/or by immersion in a cleaning fluid. For maximum effect rotating type spray heads are recommended. Sterilization in place (SIP) is possible with temperatures up to 145°C.
- A wide range of operating controls are supplied from a simple stand-alone panel to a fully integrated automation system.
- The Female bearing (rotating bearing) in the centre of the impeller body is Silicone Carbide.
- The Ultra Clean Mixer has been designed to meet the critical standards of the Pharmaceutical and Biotech industries
- Magnetic Mixer complies with current Good Manufacturing Practices and the requirements of Indian, British and the United States Pharmacopoeia of Water for Injection. All documents related to Factory Acceptance Test (FAT) like Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ) are provided as a part of the operating manual.
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Application
- Injectables
- Vaccines
- Serums
- Plasma Fractions
- Suspensions
- Infusion Solutions
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HIGH SHEAR ONLINE MIXER
INTERTECH has substantial experience in designing, fabrication, erection & commissioning of Large Volume Parental Mixing Solution System based on Online High Shear mixing Technologies. In this design, no internal agitators are fitted which leads to no cross contamination & deviation in cleaning validation. Entire vessel from inside is electro polished leaving no space of crevices & ridges henceforth no place for any bioorganic to exist. This design is economical in investment & have far better flexibility in batch size variation as High Shear Homogenizer / Emulsifier is externally fitted in re-circulation. Online temp. mapping of re-circulatory pipe line & all points well within tanks are there for cleaning validation. Head of external homogenizer is quick release type & compatible to sterilization. Agitator seals are capable of sustaining Pure steam pressure for SIP cycle.
Better & faster dissolution of solute into main WFI stream is achieved in this design as mixing is done at higher RPM & re-circulation of mixed liquid is at tangential position in tank. Therefore vortex created also enhances mixing.
CONSTRUCTION DETAILS
- Inside the Online Homogenizer, there is provision of 2 stage to 4 stage disintegrating head which are capable of dissolving any solute by high shear impact made of 316L stainless steel housing.
- Entire Mixing Tank is design of internal pressure for SIP cycle & for Vacuum application also.
- A drive unit mounts externally to the vessel and can be quickly and easily removed using a TC type connection. This is particularly useful when sterilizing the vessel & autoclave for Homogenizer parts.
- The vessel can be cleaned in place (CIP) using spray balls and/or by immersion in a cleaning fluid. For maximum effect rotating type spray heads are recommended. Sterilization in place (SIP) is possible with temperatures up to 145°C.
- A wide range of operating controls are supplied from a simple stand-alone panel to a fully integrated automation system.
- The Ultra Clean Mixer has been designed to meet the critical standards of the Pharmaceutical and Biotech industries
- These Mixer complies with current Good Manufacturing Practices and the requirements of Indian, British and the United States Pharmacopoeia of Water for Injection. All documents related to Factory Acceptance Test (FAT) like Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ) are provided as a part of the operating manual.
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