Prix FOB
Obtenir le dernier prix50000 ~ 500000 USD / Case ( Negotiable )
|1 Case Minimum Order
Pays:
China
N ° de modèle:
LM
Prix FOB:
50000 ~ 500000 USD / Case ( Negotiable ) Obtenir le dernier prix
Localité:
-
Prix de commande minimale:
50000 per Case
Commande minimale:
1 Case
Packaging Detail:
Wooden case
Heure de livraison:
3 months
Capacité de Fournir:
100 Case per Year
Payment Type:
D/P, D/A, L/C, T/T
Groupe de produits :
China
Personne àcontacter Zhihua
Shanghai, Shanghai
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-dryingÂ
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
2.1Â Â Relevant Regulations In *1CFR Part
*1Â
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.
2.2Â Â *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. Â
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
SpecificationsÂ
3.1Â Â General DescriptionÂ
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
3.2Â Â 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:Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â
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               Â
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.
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| Pays: | China |
| N ° de modèle: | LM |
| Prix FOB: | 50000 ~ 500000 / Case ( Negotiable ) Obtenir le dernier prix |
| Localité: | - |
| Prix de commande minimale: | 50000 per Case |
| Commande minimale: | 1 Case |
| Packaging Detail: | Wooden case |
| Heure de livraison: | 3 months |
| Capacité de Fournir: | 100 Case per Year |
| Payment Type: | D/P, D/A, L/C, T/T |
| Groupe de produits : | Freeze drying |
