EPC FOR INDUSTRIAL
PHARMACEUTICAL EPC
Value Engineering And GMP Turnkey Services
EPSILON LIMA provides high added-value solutions in consultancy, engineering and construction of pharmaceutical plants and complete laboratories for the manufacture of medicines, including critical equipment. This encompasses validation, regulatory compliance and implementation services for logistics management and maintenance systems.
We have strong technical power and absorbed the technical essence from abroad constantly. With the cooperation of researching institute and designing institute, EPSILON LIMA offers Turnkey Services, which fully comply with GMP requirement. We continue to promote quality system for global customers and strengthen our core competitiveness to move forward serving the pharmaceutical industry.
PHARMACEUTICAL EPC SOLUTION
EPSILON LIMA has a team of consultants with extensive professional experience in the production departments, quality, engineering, research, and pharmaceutical industries records. From the initial concept starting with an idea, to the final approval by national and international regulators, we will guide you safely in the whole process. Advice EPSILON LIMA partner early with our customers. This early engagement in your automation program helps to reduce the entire project time by sharing information and engineering ways to reduce risk, reduce cost, optimize manufacturing processes, integrate compliancy into automation and choose the best automated solution and partners for your process. Although substantial knowledge can be gained by computer modeling of food production processes, this information has seldom been used in the past for process systems design in the food industry. Due in part to the batch nature of traditional processes, the actual approach was frequently in the domain of intuition or “what worked in the past.” Site Planning The site master plan is an elementary plan that shows overall development based on a conceptual study defining the initial requirements of building spaces, flows, connections between buildings, logistics, urban design, infrastructures, and ancillary facilities, among others. It provides a structured approach and creates a clear framework for developing an area. Several drawing will be able to plan the space whilst being mindful of the GMP regulations for the product. A clear site planning will avoid future cross contamination issues.
Engineering Design
EPSILON LIMA engineering capabilities comprise of proven processes and best practices which guarantee Quality by Design implementation from the outset and looks to provide integrated design, construction and GMP compliance. EPSILON LIMA takes into account the different flows of personnel, raw materials, packaged and finished products, as well as electricity, steam, pharmaceutical water and other industrial services focusing on a good energy saving, utilities efficiency and an increase in environment productivity.- Pharmaceutical Process Installations
- Production and Packaging equipment
- Clean Rooms
- Air Systems HVAC
- Dust Collection
- Electricity & Control
- Fire Fighting
Project Execution
When it comes to designing and building custom pharmaceutical machinery, you need a supplier Engineering Design with broad capabilities, experience. EPSILON LIMA start the project execution from the machinery manufacturing based on the machinery design settled in the engineering design step. After the shipment, workers will arrive onsite for cleanroom, machinery, and auxiliary facilities setup. Machinery Design & Construction Designing and building machines that have never been built before is part of our daily challenges, and we are proud to deliver the most innovative solutions to help our clients with their needs. EPSILON LIMA has mechanical engineers specialized in aseptic filling, solid production, and liquid filling. Designing and building machines is part of our daily challenges, and we are proud to deliver the most innovative solutions to help our clients with their needs. Cleanroom Critical Installation A Cleanroom is an environment with surfaces that don’t emit particles, prevent dirt accumulation and are easy to clean. It is the most important part in the whole process. EPSILON LIMA offers an integral cleanroom installation to ensure production safety:- Flooring
- Walls and ceiling sandwich panel
- Joint sealing and corner profiles
- Windows and passing box
- Door interlocks
- Lighting
- HVAC air treatment
- Purified Water System
Project Management & Validation
During the project validation & qualification, our specialized technicians develop protocols, calibrate, and validate according to ISO, FDA & EMEA GMP, GLP standards and national/international regulations.Project Process
Process Supervision Project management a critical element in building complex machinery for the pharmaceutical industries. Project manager, process engineers and designers are assigned to each project. They are involved earlier in the project to define or review the scope of work. Process Qualification EPSILON LIMA has a highly qualified team of technicians experienced in qualification process DQ,IQ,OQ,PQ following the validation master plan and applying the highest standards: ISO, GMP and FDA. Trial and Training The last but not the least before we finish up the project is the production trail run and personnel training. EPSILON LIMA weight our responsibility as our reputation. EPSILON LIMA will accompany our customer to successfully produce three batch of product and provide throughout training program.
MORE PHARMACEUTICAL TECHNOLOGIES EXCLUSIVES
Pharma Extruders |
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EPSILON LIMA is pioneer in the development of high-end closely intermeshing, co-rotating twin screw extruders. We possess a unique know-how and an extraordinary wealth of experience in this continuous production process. Since the beginning of pharmaceutical extrusion we have continuously set new standards in the continuous manufacturing of pharmaceutical products with our special ZSK pharma extruders. This begins with special applications on a laboratory scale and extends right through to continuous pharmaceutical production systems. |
Process Equipment |
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EPSILON LIMA 's material handling equipment and components are designed for a wide variety of applications in the plastics, chemicals, food and pet food, pharmaceutical, minerals and nonwovens industries. Our components ensure that all aspects of the complete process system conform with the most current process design standards. |
Plants & Systems |
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From manufacturing through to the end product - We provide individually tailored plants for the plastics industry as well as customized systems for all processes along the process chain for a large number of applications of various industries. |
Automated Batch Dispensing |
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Automated dispensing systems are utilized throughout the pharmaceutical industry for the transfer and weighing of excipients, active pharmaceutical ingredients (API’s) and lubricants into a variety of containers and processes. The use of screw feeders in both loss-in-weight (LIW) and gain-in-weight (GIW) dispensing systems ensures the accurate metering of the product to the process or container below. Coperion K-Tron’s integrated material handling and feeding systems are available in a variety of dispensary configurations, dependent upon the material to be transferred, the containment levels required and the process requirements |
Tablet Coating and Press Lubrication |
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Tablet press lubrication and powder dispersing for tablet coating are both processes which can be significantly enhanced using Coperion K-Tron pharmaceutical feeders. Recent co-operation of EPSILON LIMA X-Tron with a number of tablet press manufacturers led to the development of feeders which feed a variety of lubricant powders direct to the press tooling by means of a gas injector. The gas in the pneumatic conveying line conveys the lubricant to a nozzle which uniformly coats all surfaces of the tablet press tools that are in contact with the granulate. Alternatively, EPSILON LIMA X-Tron screw feeders are also used in conjunction with tablet coating machines, both batch and continuous, to meter the powdered materials direct to the coating machine. Finally, the EPSILON LIMA X-Tron line of vibratory feeders are specifically designed to accurately deliver the uncoated tablets direct to the coating machine. All three operations described provide more efficient handling of the tablets, lower risk of over lubricating the tablet granulation, less off-spec tablet production and even dispersion of the powdered material on the tablet surface. |
Continuous & Semi-Continuous Applications |
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As the pharmaceutical industry continues to accelerate the current paradigm shift in pharmaceutical processing from batch to continuous, EPSILON LIMA X-Tron have continued to be technology leaders in this mode of manufacture. Our high-accuracy loss-in-weight feeders, integrated pneumatic refill systems, and continuous pharma extruders have become critical components of various continuous and semi-continuous processes, such as continuous direct compression, continuous wet and dry granulation and hot melt extrusion, milling and micronization, and continuous coating. Our loss-in-weight feeders, pneumatic systems and extruders are available in hygienic easy clean executions, with options on various modes of product containment, cleaning, and accessibility. Extensive continuous process knowledge, as well as design expertise in handling even the most difficult excipients and active ingredients have made EPSILON LIMA X-Tron the industry leaders in continuous manufacturing technology. |
Vacuum Conveying for Pharma Applications |
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The EPSILON LIMA X-Tron line of pneumatic conveying equipment and the Coperion line of components are specifically designed with cleanability as well as product and operator safety in mind. The P-Series line of pneumatic conveyors are designed to convey delicate materials such as tablet granulations, active pharmaceutical ingredients, a wide variety of excipients and even finished tablets. The P-Series of vacuum conveyors are designed with ease of disassembly in mind. They are available as standalone units as well as integrated packages for the automated refill of EPSILON LIMA X-Tron pharmaceutical design feeders. Complete systems packages are also available for conveying pickup options from supersacks, drums, boxes, IBCs and FIBCs. |
WHY CHOOSE
EPSILON LIMA FOR YOUR PHARMACEUTICAL PLANT?
- Automated batch dispensing utilizing the EPSILON LIMA X-Tron line of high accuracy load cells and control systems ensures the highest accurate delivery of even the most difficult pharmaceutical ingredients.
- The EPSILON LIMA X-Tron pharmaceutical feeder, in both volumetric and gravimetric designs, is designed specifically for the pharmaceutical industry, with ease of assembly, disassembly and cleaning in mind.
- The EPSILON LIMA X-Tron Global Systems Engineering group can supply integrated dispensing and batching systems completely integrated with a wide variety of processes, including batching from filter dryers and centrifuges, or batching directly to mixers or reactors.
- The EPSILON LIMA X-Tron line of pneumatic conveying systems provide completely contained transfer of the raw material direct to the batching system.