Our pharmaceutical lyophilizer works at a corporate level and is compliant with cGMP standards. It also has exact control systems. With a build made of AISI 316L stainless steel and advanced PLC automation, it keeps the shelf temperature consistent within ±1°C of -55°C to +80°C. The system can hit a vacuum level below 1 Pa, which makes sure that sublimation works as well as it can. Our equipment is certified by CE, ISO, UL, and SGS, and it can handle group processing on a small or large scale, from the lab to a business setting. For tough jobs, it can operate at -80°C and have two cold traps set up in different ways.
This high-tech freeze-drying device keeps APIs, biologics, and injectable formulas stable even when they are heated. Controlled sublimation gets rid of solvents while keeping the purity of the result. Management of freeze times, temperature tracking, and pressure control can all be done automatically, which is good for your production. The tablet interface makes it easier to use, and built-in safety features protect against too much pressure and heat.
15+ Years of Manufacturing Excellence
Xi'an Bioland Instrument brings over 15 years of specialized experience in chemical process equipment. Our dedicated R&D team understands your pharmaceutical manufacturing challenges.
Certified Quality Standards
We hold CE and ISO certifications, ensuring every unit meets international safety and quality benchmarks. All products comply with GMP/FDA standards for pharmaceutical applications.
Customization That Fits Your Needs
You get tailored solutions through our OEM/ODM services. Whether you need specific tray configurations, material upgrades to SS316L, or custom capacity designs, we adapt to your requirements. Customized equipment ships within 30 business days, while standard models are ready in 5-7 days.
Complete Production Transparency
Your dedicated specialist provides weekly progress updates with photos or videos. Before shipment, you receive detailed inspection materials or can schedule a Factory Acceptance Test at our facility.
Comprehensive Support Package
Enjoy one-year quality warranty with lifetime maintenance. Our experienced engineering team offers technical consultation, installation guidance, and responsive after-sales service.
Flexible Logistics Solutions
Choose from sea, rail, or air freight options to match your timeline and budget.
|
item\spec |
unit |
GZLS 0.5 |
GZLS 0.8 |
GZLS 1 |
GZLS 2 |
GZLS 3 |
GZLS 6 |
GZLS 8 |
GZLS 10 |
GZLS 14 |
GZLS 20 |
GZLS 40 |
|
capacity area |
mm |
0.5 |
0.8 |
1 |
2 |
3 |
6 |
8 |
10 |
14 |
20 |
40 |
|
walid layers |
layers |
2 |
3 |
4 |
4 |
4 |
5 |
7 |
7 |
7 |
10 |
18 |
|
max. bulk |
mm |
1052 |
1578 |
2104 |
4208 |
6312 |
11835 |
16519 |
23092 |
29456 |
42080 |
84160 |
|
layer distance |
mm |
120 (it is adjustble to meet diffrent reqirement) |
||||||||||
|
layer temp. |
|
-45-70 |
||||||||||
|
layer erance |
|
± 1 |
||||||||||
|
corks |
|
manual |
hydraulic |
|||||||||
|
vacuum |
Pa |
1 |
||||||||||
|
condenstion capacity |
kg |
5 |
8 |
10 |
20 |
30 |
60 |
80 |
100 |
140 |
200 |
400 |
|
condenstor working temp. |
|
-55- -18 |
||||||||||
|
anti-frost |
|
showering and watering |
||||||||||
|
working environment |
|
temperature 5to 35 relative humidity ≤ 80 |
||||||||||
|
cooling water |
|
≤ 28 |
||||||||||
|
demension L*W*H |
mm |
1400× |
1400× |
2450× |
2800× 1250× 2500 |
3200× |
3900× |
4200× |
4200× |
4500× 2250× 3800 |
5000× 2700× 4200 |
6000× 3500× 4200 |
|
power |
kw |
5.0 |
6.5 |
7.5 |
12 |
20 |
40 |
50 |
55 |
75 |
100 |
180 |
|
cooling water capacity |
T/h |
|
|
2 |
3 |
5 |
10 |
13 |
15 |
20 |
30 |
60 |
|
controller |
|
programming |
||||||||||
|
weight |
kg |
1000 |
1150 |
1300 |
2500 |
3500 |
6000 |
8000 |
9000 |
12000 |
16000 |
23000 |
|
note |
|
air cooling |
water cooling |
|||||||||
There are three separate steps that the pharmaceutical lyophilizer takes to keep your product's bioactivity:
Freezing Phase
Your product solution has been cooled below its eutectic point, which is also known as the temperature at which it turns into glass. Controlled formation of ice crystals sets the stage for effective melting.
Primary Drying (Sublimation)
The chamber pressure drops to a vacuum, and the temperature of the shelf slowly rises. Ice doesn't go through the liquid state before it turns into a vapour. About 95% of the water is taken out during this time.
Secondary Drying (Desorption)
While keeping the vacuum, the temperature rises even more. The end moisture content is usually less than 2% because the bound water molecules split from the product matrix.
The PLC control system keeps an eye on important process factors during these stages. Temperature probes, pressure monitors, and automatic valves all work together to keep things in good shape. This makes a strong, open cake structure that quickly comes back together.
Biologics and Vaccine Manufacturing
During the drying process, your monoclonal antibodies, live attenuated vaccines, and synthetic proteins keep their tertiary structure. This is an important use for goods that need to stay stable for a long time but can't be kept in a cold chain.
Sterile Injectable Medications
Handle stock or vials of beta-lactam antibiotics, cephalosporins, and other drugs that are injected. As long as the system stays sterile, it can handle batch amounts ranging from small scale to full commercial production.
High-Potency Active Ingredients
Combine with isolation isolators for chemicals that kill cancer cells. The tight design keeps workers safe and keeps your goods in ISO Class 5 conditions.
Diagnostic Reagents
Keep molecular test kits, enzymes, and antibodies stable. The gentle process of freeze-drying keeps the energy for a longer shelf life.
Cell and Gene Therapies
Our product gives these sensitive biological materials very exact control, which is useful for new cell-based treatments.
Our manufacturing facility holds ISO 9001 quality management certification. Each unit undergoes rigorous testing including:
We provide comprehensive documentation including:
All equipment ships with CE certification and material traceability for stainless steel components meeting pharmaceutical grade standards.
FAQ
Q: What causes cake collapse during drying?
A: Collapse occurs when product temperature exceeds its critical collapse temperature (Tc). We help you optimize cycle parameters based on your product's thermal properties to prevent this issue.
Q: How do you ensure sterile conditions?
A: The system uses 0.22 µm hydrophobic sterilizing-grade filters on venting lines. Optional Steam-in-Place (SIP) and Clean-in-Place (CIP) systems provide additional sterility assurance.
Q: Can your equipment handle organic solvents?
A: Yes. For organic solvent applications, we configure the product with explosion-proof components and appropriate vacuum pump technology to safely handle flammable vapors.
Q: How is primary drying completion determined?
A: Advanced units include comparative pressure measurement (Pirani vs. Capacitance Manometer) to detect the endpoint when vapor mass flow drops significantly.
Q: What maintenance does the system require?
A: Annual inspection of heat transfer fluid, vacuum pump servicing per manufacturer guidelines, and regular calibration of temperature and pressure sensors. We provide detailed maintenance schedules with each unit.
Q: Do you offer validation support?
A: Yes. Our technical team assists with IQ/OQ/PQ documentation and can guide you through validation master plan requirements.
Ready to enhance your pharmaceutical production capabilities with pharmaceutical lyophilizer? Our engineering team is standing by to discuss your specific freeze-drying requirements. Contact info@biolandequip.com for technical consultation and quotation.
2024-05-16
Pharmaceutical Company
The reactor is beautifully mirror-polished and fully complies with GMP requirements for the pharmaceutical industry. The performance is excellent! Overall, we are very satisfied! We also provided with some feedback on our process improvements, which we hope will be helpful.
2024-04-09
Laboratory
Excellent and professional service. Always reply our questions very fast. All reactors and chiller we received are good too.
2024-02-15
Research Institute
Quality is beyond our expectation actually. After we got the extraction equipment and started using it, the performance was beyond our expectation. Very easy to use and very efficient to run. Service always respond us very quickly. Was also very helpful to help us. Thanks Bioland team. Very happy to work with you.
2023-11-20
Biotech Company
We are happy about the new purchase as always. Equipment and services are both good.
2023-08-05
Instrument Lab
This is the second order with Bioland instrument and everything is good as the first dateText.
2023-05-12
Global Trading Partner
Bioland instrument team is very helpful and professional. The sales helped us select the right equipment for our application, and their logistics people handled the transportation and customs declaration for our shipment. All that saved us a lot of work.
