ONCOLOGY STERILE SECTION

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Custom designed isolators for dispensing and/or sampling from various containers such as bags and drums into intermediate packaging or for direct charging into process equipment. These systems offer high containment and a controlled environment offering fast cleaning and drying features allowing for swift product changes.

Depending on the type of incoming packaging, the systems can be equipped with an airlock, a Rapid Transfer Port (RTP) or a drum docking system for material entry.

Dispensing and/or sampling isolators can be equipped with multi-scale systems including data acquisition and possible connection to an MES system for recipes management.

Other equipment such a sieves or mills can be integrated depending on the process requirements.

The isolators can be either equipped with a lower chamber for drum or liner charging, a split or SafeDock Valve for charging into an intermediate receiver or a hopper for powder conveying by Powder Transfer Syste  to actively charge a reactor, an IBC or a blender.

 We offers a range of primary packaging solutions for aseptic filling of vials, syringes, bottles and cartridges as well as Dual Chamber Syringes (DCS) and systems.

We have proprietary technology for highly accurate, (semi-) automated filling methods for low or high production volumes for both powders and liquids. 

Our solutions span a wide range of possibilities from standard to tailor-made to accommodate specific customer needs.

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Our filling lines can be fully integrated into containment systems (oRABS, isolators, etc.) for sterile and highly contained operations. We also modify existing equipment for upgrades to optimize production efficiency.

• Fill-finish machines are custom designed for various types and sizes of containers.
• Our Unique design can combine powder and liquid injection filling in a single machine
• Single and double-chamber syringes, ampoules, cartridges, nested containers RTU, vials, single and multi-chamber IV bags
• Designs accommodate low, medium, and high output ranges
• Modular components for increased flexibility and reduced design time
• Servo drive technology for increased precision, flexibility and reliability
• High filling accuracy up to +/- 0.05% 
• Up to 100% in process control verification
• Compatible with laminar flow or isolator units and RABS for environmental control.

 If you are looking for filling systems for different products such as liquids, powder or flow-resistant highly viscous materials, we provides a modular concept allowing to meet a variety of packaging that is appropriate in the field of research and development as well as clinical trials. Speed up your go-to-market strategy with innovation and modular thinking. 

• Laboratory and small scale aseptic/contained production
• Various solutions for the supply of packaging materials
• Integrated environmental monitoring
• Highly accurate, patented filling technologies for powders, liquids and gels
• Various aseptic  containment systems (oRABS, Isolators)
• Highly integrable, reflecting continuous manufacturing single source solutions.

Containment Control Strategies  (CCS)  to separate the operator from the aseptic core - are a design priority for all our fill-finish machines to comply with Annex 1.

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• oRABS, isolators
• Robotic systems
• Single-use systems
• Advanced transport methods
• Advanced monitoring and control systems.

 Our equipment is configured for a seamless integration into your production lines and designed to accommodate various speeds and containers, including RTU / RTF (ready-to-use or fill) bottles, vials, cartridges, syringes, pre-sterile nested trays and combined powder and liquid filling for dual chamber systems. Filling methods for liquids/gels: BoMa technology, net weight filling, peristaltic pump, rotary piston pump Microdosing technologies for powder: μPTS, flexPTS, sPTS, Auger system 

• Great flexibility in labeling various container types and sizes
• Size parts are easily changed without tools
• Plunger rod and backstop assembly unit
• The print station is equipped with a hot-foil, thermal transfer, ink jet, or laser printer
• Labels are accurately placed on each container
• Servo-driven for high precision

 A sterility isolator is a system that allows operators to perform sterility tests in an aseptic environment. They are often used in the pharmaceutical industry to perform microbiological control activities and sterility tests on production batches.  

Here are some features of sterility isolators:  

• Aseptic environment Sterility isolators are designed to create a sterile environment for testing.  
• Controlled loading and removal Sterility isolators have a controlled method for loading and removing products and waste materials.  
• Monitoring and control : Sterility isolators are monitored and controlled to maintain strict environmental conditions.  
• Customizability Sterility isolators can be custom designed to meet specific customer requirements.  
• Ergonomics Sterility isolators are designed to maximize operator effectiveness and comfort.  

A lyophilizer, also known as a freeze dryer, is a machine that removes water from substances to preserve them, extend their shelf life, or make them easier to transport. 

 Lyophilizers work by:

1. Freezing the material
2. Reducing the pressure
3. Adding heat to allow the frozen water to sublimate  

Lyophilization is a dehydration process that bypasses the liquid phase. It's commonly used in the pharmaceutical and biotechnology industries.  When choosing a lyophilizer, you can consider the type of condenser it has:

• Internal condenser: Less expensive and provides unrestricted vapor flow
• External condenser: Has an isolation valve that separates the product from the condenser, protecting it from reconstitution during power loss 

Command room data monitoring
- Temperature: sample, shelves, condenser, refrigeration system
- Pressure: vacuum, chamber
- Alarms: sensor failure, condenser overheat, over current, oil circulation failure, motor overheat, heater
malfunction, condenser temperature error, vacuum failure, heat media circulation problem
- General data: Process status including pre-freezing,

Control system
User friendly interface and 10”TFT touch screen provide convenient control and monitoring.
Also all events during process are recorded and recipe set up function allows easy processing with various conditions and materials.

Control function
- Operation status can be monitored by PC through RS/232(485) communication port.
- Data management by USB (Touch optional) Drying time record is stored.
  Vacuum pump usage time is recorded for timely maintenance.
- Parameter unit is convertible for user's convenience. (℃ ← → ℉, mTorr ← → mBar)
- Line voltage is displayed for protection of machine. (Low/high voltage).

Why LP MASTER software?
Stability and credibility are first priority for biological and pharmaceutical application of freeze drying. 
Therefore precise and reliable control and monitoring are very critical for successful freeze drying process and 
such precise monitoring software must be required. Our authentic monitoring/control software is designed to comply with FDA guideline with flexibility to meet various changes. 
It also gives abundant libraries to meet satisfactory compliance for user’s various requirements.

Software Library
- Process monitoring: Comprehensive data supply through entire drying process allows you to have optimal condition and best recipe.
- Recipe management: Automatic operation is available by selection of saved recipe that can be expanded further.
- Audit Trail : All data from system is traced and monitored.
- User Access: Only authorized user can manage operation, control and monitoring by security library access.
- SCADA System: Choice of data management and record management period are available.
- Vacuum Integrity test Library: Test on vacuum of chamber before drying process.
- Trend: Graphic data management of accumulated real time data (drying / SIP / CIP - Conductive).
- 21 CFR Part 11 compliance