Sterile Manufacturing Plant
The Sterile Manufacturing Plant in the Pharmaceutical Industry is one of the most widely used and important units for producing Pharmacy Products. LITCO has established itself as one of the most efficient manufacturers of Sterile Manufacturing Plant as we make customised plants as per requirement with our enormous experience and attention to detail design.
LITCO’s standard Sterile Mfg. Plant consists of the following:
- Sterile Mixing Vessel ( Magentic / Mixing Anchor)
- Sterile Storage Vessel
- Powder Feeding System
- In-line Homogenizer
- Membrane Filter
- Cartridge Filter
- Vacuum System for Online Transfer
- Plant Pipeline
- Aseptic Valves
- Automated Control Panel
In our Sterile Manufacturing Plant, we can produce
- IV Fluid
- Sterile Solution
- Large/Small Volume Parenteral Drug
- SVP Solution
Working Principle Of Sterile Mfg. PlantThe Sterile Manufacturing Plant is designed to produce aseptic products hence sterility and automation is most important, to ensure minimal contact. According to requirement, the Sterile Mixing Vessels are placed with the provision for a powder feeding system. The Sterile Mixing Vessels are provided with an Anchor type Agitator for homogeneous mixing of the materials. The Anchor type Agitator can be a Mechanical/Magnetic Stirrer. The Magnetic Stirrer is most recommended to ensure least contamination and contact. The product is then passed through an In-line Homogenizer for further mixing. Then it is made to pass through a series of Filters such as the Membrane or Cartridge Filter depending upon the user’s requirement. The entire transfer is handled by an Online Vacuum Transfer system for the best productivity and ease of use. Another important aspect in Sterile Mfg. Plants is to ensure no Dead Legs to prevent unwanted microbial growth. Hence Zero Dead Leg Valves with other Aseptic Valves are provided according to the plant design to prevent impurity formation. The produced Sterile solution is finally transferred to the Sterile Storage Vessel which is then carried forward for packaging or other processes. The entire process is undertaken by our smart Automated Control System with an easy-to-use HMI ensuring all the processes are completed on-time, efficiently and hassle-free with no manual handling. At LITCO, we manufacture Sterile Manufacturing Plant as per our Customer’s requirements. We specialise in providing our Client’s customised Plant design and Turnkey solutions. Please drop in your requirements under our Contacts for further specifications and quotations.
- Complete aseptic design with Magnetic mixer & high shear Magnetic emulsifier.
- Zero dead leg aseptic design Flush bottom outlet diaphragm valve with SIP facility.
- Sampling valve zero dead leg type with CIP/SIP facility.
- Volume monitoring by Load Cell for accurate measurement and result.
- PH Sensor / Conductivity Sensor provided on demand for online check Product PH & Conductivity.
- The gaskets used are of Silicon (food grade) to avoid contamination
- Mechanical Seal is provided at the Stirrer Entry to prevent back-flow and contamination.
- All material transfers are done by vacuum hence assuring minimal contact.
- All the Vessels are CGMP standard (paint free construction).
- All contact parts are made of SS 316 grade and non-contact parts SS 304.
- All pipelines are joined with Tri-clover ended Joints assuring safe and smooth transport.
- PLC with HMI Touchscreen with CFR 21 Part 11 complied with SCADA for full Automatic Control & Processing.
|Capacity||50 Litres.||100 Litres.||500 Litres.||1000 Litres.||2000 Litres.||5000 Litres.||10000 Litres.|
|Gross Capacity||60 Litres.||120 Litres.||600 Litres.||1200 Litres.||2400 Litres.||6000 Litres.||12000 Litres.|
|MOC||·All Contact Parts SS316 ·All Non-Contact Parts SS304||·All Contact Parts SS316 ·All Non-Contact Parts SS304||·All Contact Parts SS316 ·All Non-Contact Parts SS304||·All Contact Parts SS316 ·All Non-Contact Parts SS304||·All Contact Parts SS316 All Non-Contact Parts SS304||·All Contact Parts SS316 All Non-Contact Parts SS304||·All Contact Parts SS316 All Non-Contact Parts SS304|
|Heating Element||Electrical/Steam Heater||Electrical/Steam Heater||Electrical/Steam Heater||Electrical/ Steam Heater||Electrical/ Steam Heater||Electrical/ Steam Heater||Electrical/ Steam Heater|
|Material of Insulation||Glass Wool||Glass Wool||Glass Wool||Glass Wool||Glass Wool||Glass Wool||Glass Wool|
|Insulation||50 MM||50 MM||50 MM||50 MM||50 MM||50 MM||50 MM|
|Agitator Location||Top/ Bottom Fixed Stirrer||Top/ Bottom Fixed Stirrer||Top/ Bottom Fixed Stirrer||Top/ Bottom Fixed Stirrer||Top/ Bottom Fixed Stirrer||Top/ Bottom Fixed Stirrer||Top/ Bottom Fixed Stirrer|
|Motor||1 HP, 50-960 RPM, TEFC, ISI make motor||1 HP, 50-960 RPM, TEFC, ISI make motor||3 HP, 50-960 RPM, TEFC, ISI make motor||5 HP, 50-960 RPM, TEFC, ISI make motor||7.5/10 HP, 50-960 RPM, TEFC, ISI make motor||15 HP, 50-960 RPM, TEFC, ISI make motor||30 HP, 50-960 RPM, TEFC, ISI make motor|
|Power Supply||415 V / 50 Hz/3 Ph/AC||415 V / 50 Hz/3 Ph/AC||415 V / 50 Hz/3 Ph/AC||415 V / 50 Hz/3 Ph/AC||415 V / 50 Hz/3 Ph/AC||415 V / 50 Hz/3 Ph/AC||415 V / 50 Hz/3 Ph/AC|
|LITCO manufactures Customised Injectable/Sterile Processing & Packaging Plant as per Customer’s requirements apart from these Standard Models.|