Shinva Freeze Dryer, Lyophilizer, Freeze Drying Machine
| Price: |
Negotiable/Piece |
| Trade Terms: |
FOB,CIF |
| Min Order: |
1/Piece |
| Pay Type: |
L/C,T/T |
SHINVA is a comprehensive company who is sophisticated for manufacturing pharmaceutical equipment.
In order to fulfill the most sophisticated and customized requirement of the pharmaceutical industry. Shinva is continuously dedicating for bring quality and reliable freeze drying system. From all of details which starts from design, manufacturing process and Quality testing of freeze dryer which are approved by cGMP, FDA regulation and ISO-9001 quality management system.
We are capabile to present freeze dryer from laborotary scale to mass production.
Ice capacity from 4Kg to 1000Kg.
We are focusing to do as follow:
Providing freeze dryer with customized requirement.
Providing freeze dryer with auto loading/unloading system
Providing freeze dryer with manual/semi-auto loading/unloading system
Providing freeze dryer with API loading system and solution
Providing freeze dryer with integrated project solution and equipment
Providing freeze dryer with lyophilization cycle optimization
Providing technical training/servicing to bring productive solution
Honestly we would like to maximize your benifit in your project
We are looking forward to see you in your next project.
We are providing some type of freeze dryer and customized according to your requirement.
Specification of freeze dryer as follows:
DESCRIPTION
1. General description of Freeze-drying
Freeze drying can occur naturally, but it was not until the end of the 19th century that it was discovered that the process could be accelerated by the application of vacuum. In freeze drying, liquid is removed from a substance directly from the solid (frozen) state, under vacuum, to the vapor state. This process is known as sublimation, and a freeze drying cycle has stages as follows:
Preparation (pretreatment): such as production of Food class, API, formulations, sterilization, container preparation, filling, half stoppering of formulated drug; program selection
l Freezing (or pre-freezing): freeze products to solid state;
l Primary drying(sublimation): this is the part of the process when the frozen water is converted from ice directly to vapor;
l Secondary drying(desorption drying): this is the part of the process where the remaining small proportion of bound liquid is removed;
l Sealing and packaging: dried products are sealed and packaging under vacuum or inert gas.
Freeze drying [lyophilization] has the advantages of preventing protein from degeneration and preserving the efficacy of the dried material, with long expiry periods. Historically lyophilization provides a very short time to providing a stabile product and that is what prompts its use in the pharmaceutical industry. At present, lyophilizers are used for biological-products, pharmaceuticals and foods and many other products. To supply the rising demand for lyophilizers in the in these industries was formed by us for the manufacture of freeze dryers according to the current codes and standards.
2. Relevant GxP Regulations
2.1 Relevant Regulations In 21CFR Part 11
Design of equipment construction and dimension is according to 21 CFR Part 11 subpart D (Definition of Equipment Used in Drug Product) Equipment used in the manufacture, processing, packing, or holding of a drug product shall be of appropriate design to facilitate customer operations for its intended use and for its cleaning and maintenance. Equipment shall be constructed so that surfaces that contact components, internally, shall not be reactive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product.
Materials such as refrigerants, thermal oils used for lyophilizer and so on, shall notcontact with components, drug product containers, closures, in-process materials, or drug products so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
Appropriate controls shall be exercised over computer or related systems to assure those changes in master production and control records or other records are instituted only by authorized personnel. Input and output from the computer or related system of formulas or other records or data shall be checked for accuracy. The degree and frequency of input/output verification shall be based on the complexity and reliability of the computer or related system. Hard copy or alternative systems designed to assure that backup data are exact and complete.
2.2 21 CFR Part 11 and LyoMaster Controller-300A
In the terms of Part 11, LyoMaster Controller-300A software System represents a closed system, "an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system."
Electronic Signatures:
In Part 11, electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.
Electronic Records:
Part 11 governs the following kinds of electronic records that are created by LyoMaster controller-300A software:
l Historical logs
l Event logs
l Alarm logs
l Recipe Files
Privilege manage:
There are different groups in LyoMaster Controller-300A to define the privilege as different operation level, the administrator can add and set up new member in each group. The user and group are connecting with the user and group of WINDOWS so that the safety tactic of user is same as WINDOWS.
l Engineer Group Users belonging to this group have all of the privileges
l Maintenance Group Users can only maintain the equipments and can operate the machine, but can't make a recipe for production.
l Operator Group Users belonging to this group operate the equipment, download and view recipes, but can't modify, delete or set up recipes.
3. Function Specifications
3.1 General Description
This section describes functions of each system in LMG-YD-1.0(CIP, SIP) as follows:
l Current technical specifications
l Technical parameter summation and performance index
l Machinery safety
3.2 Item Configuration
LMG-YD-1.0(CIP, SIP) based on standard design, Specific standard as follows:
Sort
| Standard
|
| Style | LMG-YD-1.0(CIP, SIP) |
| Power supply | 380V+/- 10%, 50Hz, 3 Phase |
| Electric standard | IEC60204-1,GB4728-84 |
| Measurement units | Metric/English system |
Public works of this project as follows: | Sort | Basic configuration |
| Cooling water | 5T/hr of cooling water
1.5bar≤P≤3bar
15ºC≤T≤25ºC |
| Compressed air for pneumatic valves | 45~50L/Min (5bar≤P≤8bar) |
| Nitrogen gas | 50~70L/Min (1bar≤P≤1.5bar) |
| Sterile air | 50~70L/Min (1bar≤P≤1.5bar) |
| WFI flow rate for CIP | 100L/Min (T=80ºC, 4bar≤P≤6bar) |
| WFI consumption | 500-700L (T=80ºC, 4bar≤P≤6bar) |
| Average steam for SIP | 60Kg/batch (2bar≤P≤3bar) |
| Steam for de-icing | 15Kg/batch (2bar≤P≤3bar) |
| Cooling water (For jacket cooling) | 20L/Min(7°C-15°C) |
Circulating water supply
(For liquid ring pump) | 7L/Min(7°C-25°C) |
| Overall power | 15Kw(Approx.) |
Detailed Description of carton machine:
4. Chamber
Chamber is a closed vessel in which product is placed to be dried and includes chamber, door, and shelf stack and so on; it is connected with condenser through an isolation valve to provide a closed environment for products during a vacuum lyophilizing process:
Reinforcement ribs are joined outside of chamber and covered by stainless steel sheet metal to form hollow structure, which is be filled with insulation foam, meanwhile, the stainless steel cover is welded on the chamber, the roughness of the surface is less than or equal to 0.75µmRa. Machine room and aseptic room are separated by the aseptic room wall to meet sealing requirements in pharmaceutical industry. there is door sealing gasketed groove on contacting areas of chamber and door used for vacuum sealing and steam pressure during freeze drying and the cleaning and sterilization processes.
All internal corner surfaces are ground smooth and polished. The internal surface of the chamber is mechanically polished, for easy cleaning, all corners are smooth. The pipe ports and chamber are welded by TIG, and the weld lines are polished. To ensure gravity drainage, pipe ports have a downward slope.
5. Door
The door is placed in position to be inside the aseptic room and connected with the chamber through a hinge, is pre-locked with Auxiliary manual handles; the door can open 110 degrees for maintenance. The door is made of stainless steel. The surface of the door inside is mechanically polished less than or equal to 0.4µmRa. The surface of the door is insulated and with stainless steel cover. In order to observe the chamber interior shelves and products, there is a sight glass installed on the door. And the internal door plate will be passivated, besides, a slot door is built with main door for allow products loading shelf by shelf, also, it is used for prevent contamination and loading products during shelf pre-cooling, safety light curtain is installed on the sides of slot door for protecting loading activities in case get injury.
6. Shelf stack
Shelf stack includes 4 shelves, plus 1 upper radiant shelf, supporting frame and other components. The sizes of the frame are as same as the shelves (but much higher in weight and strength to support the shelves in the up position and radiate stoppering forces uniformly during stoppering).The purpose for the uppermost shelf is to offer the same heat exchanger environment as other shelves. The entire shelf stack, 9 shelves and upper radiant shelf is removable as a complete package for maintenance purposes. The stoppering piston cylinder, which used for up and down movement of shelves, passes through a flange in the chamber and fixes on the upper radiant shelf. The shelf movement is monitored by an interlock system.
7. Condenser
Condenser type is installed in the back of the chamber and it is integrated from the chamber by a large diameter hydraulic mushroom valve. Internal surface of condenser and external surface of coils which used in evaporation are polished to less than or equal to 0.5µmRa. the mechanical of the valve disc is the same roughness with inside chamber surface.
A sight glass is provided to observe ice build up on the condenser coils. The condenser is insulated outside and is covered by stainless steel and the roughness of the surface less than or equal to 0.75µmRa. And the coils and the internal surface of condenser will be passivated.
8. Refrigeration System
Piston Compressor Screw Compressor
The refrigeration system consists of compressors with heater exchanger to chill down the temperature of products by shelf heating radiation, the coils are directly freezing by refrigerant through compressor system in which capture the vapor of products.
9. Vacuum System
Edward Vacuum Pump Leybold Vacuum Pump
The vacuum pump group consists of the main vacuum pumps,vacuum pump isolation valves and booster pump. The pump group connects with the evacuation pipe components through the single-electric isolation control valve. The vacuum pump group is used for evacuating chamber and condenser.
10. Pneumatic System and Venting System
Pneumatic system supplies compressed air for pneumatic diaphragm valves, pneumatic ball valves, pneumatic butterfly valves and door bolt used in lyophilizer. These are interlocked to achieve automatic control. The pneumatic system includes gas inlet valve, F.R.L. Unit(F.R.Unit, lubricator, relief valve), pressure relay, magnet reversing valve, pneumatic junction board, pneumatic pipelines and relevant connectors. In order to ensure the quality of compressed air, operator intervention periodically is needed, to drain water in the filter and clean/exchange filter core to reduce oil aerosols. Compressed air pressure must be higher than 7Bar. The appearance of part and pipes shall be insulated if the surface temperature could be up to 50 centigrade.
11. Control System
Principle plot of lyophilization process
Main Operation Interface
Control system is a two-layer structure based on PC-PLC. PLC is used for surveying the state of equipment; control the running of equipment and carry out corresponding control catenation, The PC is the operator interface.
The logical program was designed according to GAMP5 guideline, all the operation interface is based on IFIX control system or either SCADA control system. And supplies several function interfaces to enable manual or automatic control, data collection, and safety control. The control system supplies multilevel operation authority, and stopping all operator intervention without authority. Meanwhile, control panel in the clean room can also be used for some operations and parameter reading. Please refer to electric design of function specification for more information on these details which is built in the document. The installed components are described in following chapter.
The Siemens PLC (Programmable Logic Controller), interfaced with the SHINVA LYOMaster-300A controller, is used to control the freeze dryer logic and implement the appropriate interlocks, during manual and automatic modes of operation. The system program, program blocks and function blocks are resident in the internal RAM EPROM and can not be modified by the operator. Data blocks are resident in the internal RAM. The operator does not operate the PLC directly. The PLC operates in the background when the operator uses the PC.
| Prod Model: |
LMG for prduction, LAM for lab |
| Markets: |
North America,South America,Eastern Europe,Southeast Asia,Africa,Oceania,Mid East,Eastern Asia,Western Europe |
| Quality: |
Best |
| Brand: |
Shinva |
| Finished Dosage Form: |
Liquid |
| Certification: |
GMP FDA cGMP |
| Type: |
Pharmaceutical Equipment |
SHINVA is a leader in the design and manufacture of automatic machines for lyphilization processing and packaging of pharmaceutical products.
Appreciate to a high technological profile and the ability to offer tailor-made solutions to satisfy the most sophisticated requests of the market.
In 1943 Shinva was established to manufacture medical equipment. Shinva went public in 2002 at the Shanghai Stock Exchange. During the past 71 years Shinva has used its military heritage and culture to manufacture products according to the Qilu tradition. The Qilu Culture is a mainstream of China's traditional culture. Based on "people", Qilu Culture regards "benevolence" as a core, "gentility" as the form and "harmony between man and nature" as the goal. These thoughts have influenced China for more than 2, 000 years and also form the foundation of China's technical and capital enterprises. Shinva gains special advantages to being deeply influenced by the culture's quintessence. Qilu contributes to the evolution of the culture significantly. According to this cultural heritage Shinva pays attention to customer's needs, encourages our employees with goals, and fosters people to create the inner power needed for higher achievement. Through this cultural and enterprise background Shinva has produced nine different lines of medical and pharmaceutical equipment in the Central Supply Sterilization Systems [CSSD], Pharmaceutical Equipment, Radiotherapy, Digital Operating Room, Dental, Medical Environmental Protection, Experimental Animal Products, and In-Vitro Diagnostic Reagents and Instruments and Biomedical Materials and Supplies, all integrated solutions. Shinva is living into the future standing on this firm foundation and history of success. We have self-confidence, we are innovating and taking risks developing new products yearly and are advancing with the times. We are making a contribution to the health and wellbeing of the world by manufacturing excellent products meeting the highest regulatory standards.
