Active Pharmaceutical Ingredient (API) is defined as a kind of active
ingredient obtained by chemical synthesis, semi-synthesis, microbial fermentation
or extracting from natural products. It experienced one or more chemical
reactions and physical operations before applied to manufacture pharmaceutical
preparation. Freeze-drying of APIs features large-scale bulk
lyophilization, and the freeze-drying capacity of a single batch size ranging
from 10 to 1000kg. API lyophilization systems can be applied for freeze-drying
of sterile and non-sterile APIs, probiotics, food and health care products.
Usually, API lyophilization systems can be categorized by its loading
methods: loading with Lyophilization trays, loading with PE membrane, loading
with shelf as tray.
Conventional loading with Lyophilization trays and PE membrane have been
processed manually, by which solutions are poured into tray or PE membrane
directly and then transferred to the shelves of the freeze dryer. After
lyophilization, freeze-dried APIs are collected manually. It is obvious that
too much human intervention is involved in the whole freeze-drying process.
However,the advantages of these conventional loading methods feature low equipment cost in early stage, no need of special supporting equipment and easy cleaning and maintenance.And the disadvantages involves higher risks of contamination for non-sterile products, and not suitable for manufacturing product with toxic substance. These loading methods are widely used, especially for some products with relatively high viscosity and in small batches.
Fixed Loading Systems:
It is applied to handle highly potent active pharmaceutical ingredient (HPAPI), high sterility and high value-added products, which is most suitable for small-scale freeze dryers.
Flexible Loading Systems:
It applies to the manufacture of multitudinous products.
Although the loading methods with tray is improved continuously, due to
the door of freeze dryer keeps open in the loading process, the dispense of the
sterilized API into the trays is exposed to the ambient and the risk of
contamination no matter whether barrier systems and automatic metering and
weighing device are integrated into the loading systems. Besides, the frictions
between stainless steel trays and freeze-dryer shelves may generate insoluble
particles, which pose contamination risks to products. During the
lyophilization process, vacuuming or other operations and unloading of the
trays may still generate insoluble particles, which may bring about the risks
of the secondary contamination to products.
Shelf as tray in freeze dryer has replaced conventional one loading with tray. Freeze dryer is designed shelf as the tray with folded edges, which can be tipped at specific angles .And the API solution is charged into the shelf directly by the inlet pipe from the side of freeze dryer without opening the door or manual operations during the whole loading process, and freeze-dried API can be sucked by robot after lyophilization. The whole loading and unloading process is fully automated and unmanned.
Freeze dryers with shelf as tray are Tofflon
patent products, which are installed and operated widely in the pharmaceutical
companies’ worldwide. It can be customized according to individual output
demands from customers , the freeze drying area ranges 2~40 ㎡, and the technical features as below :
Shelves are designed as trays with 100% effective area.
API solutions are directly dispensed into shelves where heat is transferred
directly to products and production cycle is improved effectively
process of cleaning, sterilization and transportation of trays, it minimizes
the risks of cross contamination, reduces functional rooms of the factory, improves productivity as well
as reduces operating cost;
The API solution is monitored by a mass flow meter to
achieve precise feeding of each laye;
The internal structure of the chamber is simple, which is easy to clean and
Freeze Dryer with shelf as tray can integrate with
conventional loading and unloading system, such as auto-loading with robot and
semi-automatic loading with peristaltic pump.
Unloading method can be alvacuum intake robot, pulverizing & vacuum absorption robot, or Automatic scraper vehicle- is available in tipping shelves lyophilizer system.
Pulverizing & vacuum absorption robot Vacuum Intake Robot
API Features: High hardness and toughness, sticky
Loading Method: manual loading with peristaltic pump
Lyo-40 (SIP, CIP) x3, Automatic scraper discharge system
s Unloading method: complete shelf of lyophilized powder is discharged at one time by the Automatic scraper discharge system.
hygroscopic, acid corrosive, dust-prone
automatic enclosed loading with mass flowmeter
Lyo-40 (SIP, CIP) x3,
Automatic scraper discharge system
method: complete shelf of lyophilized powder is discharged at one time by the
Automatic scraper discharge system