Production freeze dryer, freeze drying machine, lyophilizer, lyophilization

详情

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****1 quality management system.




We are capabile to present freeze dryer from laborotary scale to mass production.
Ice capacity from 4Kg to ***0Kg.

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 *9th 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 *1CFR Part *1 
Design of equipment construction and dimension is according to *1 CFR Part *1 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 /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   *1 CFR Part *1 and LyoMaster Controller***0A

In the terms of Part *1, LyoMaster Controller***0A 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 *1, 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 *1 governs the following kinds of electronic records that are created by LyoMaster controller***0A software:
l  Historical logs
l  Event logs
l  Alarm logs
l  Recipe Files

Privilege manage:
There are different groups in LyoMaster Controller***0A 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
**0V+/- *0%, *0Hz, 3 Phase
Electric standard
IEC******1,GB******4
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
*5ºC≤T≤*5ºC
Compressed air for pneumatic valves
*5~*0L/Min   (5bar≤P≤8bar)
Nitrogen gas
*0~*0L/Min   (1bar≤P≤1.5bar)
Sterile air
*0~*0L/Min   (1bar≤P≤1.5bar)
WFI flow rate for CIP
**0L/Min (T=*0ºC, 4bar≤P≤6bar)
WFI consumption
******0L  (T=*0ºC, 4bar≤P≤6bar)
Average steam for SIP
*0Kg/batch  (2bar≤P≤3bar)
Steam for de-icing
*5Kg/batch    (2bar≤P≤3bar)
Cooling water (For jacket cooling)
*0L/Min(7°C**5°C)
Circulating water supply
(For liquid ring pump)
7L/Min(7°C**5°C)
Overall power
*5Kw(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.*5µmRa. 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 **0 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.*5µmRa.  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.