ACCORDIANS – CakeStand
Designed to support R&D activities in the lab, scaling up to industrial vacuum tray dryer applications, CakeStand™ offers:
CakeStand™ ensures uniform drying with direct heating shelves, providing validated temperature uniformity between the different levels.
This technology enhances heat transfer, reduces drying times, and ensures batch consistency, making it the ideal vacuum drying oven for critical applications.
CakeStand™ meets the highest industry standards for hygiene and compliance, with:
For pharmaceutical, biopharmaceutical, and fine chemical processes involving potent compounds, CakeStand™ offers:
Engineered for precision and compliance, CakeStand™ can be provided as a standalone system or with advanced automation, featuring:
ACCORDIANS – GFDLab
The GFD®Lab is an all-in-one filter dryer designed to comply with Good Laboratory Practices (GLP) for regulated research and development activities. It allows process developers and manufacturers to complete through a wide range of processes in one single system:
At PSL, we understand your product is valuable. Therefore, maximising your product yield to remain competitive in your sector is vital.
The core features of the GFD®Lab nutsche filter dryer are designed to address this crucial requirement. Upon process completion, your product batch can be easily collected by simply removing the unique filtration basket from the GFD®Lab vessel.
Additionally, the GFD®Lab basket is designed to allow quick and easy changeover of filtration meshes with various pore-sizes and materials (Polypropylene, PTFE, 316LSS, Alloy 22, etc.), hence facilitating multi-product applications.
The GFD®Lab is an innovative agitated nutsche filter dryer with a modular design that enables end-users to interchange vessels sizes from the 010 and 050 series without the need to use a different base frame.
To further enhance production flexibility, the base frame of each GFD®Lab model is also compatible with all available vessel materials (i.e. borosilicate glass, 316LSS, Alloy 22)
Due to its unique modular design, it is possible to upgrade the standard GFD®Lab Filter Dryer into a GFD®Lab PLUS model by simply retrofitting a new base frame to the existing vessel. By opting for this upgrade, the additional features allow you to speed-up development activities by automating the controls of your GFD®Lab.
The GFD®Lab PLUS allows users to build bespoke process sequences and optimise process recipes to suit particular process applications.
Production can start at a touch of a button and pre-designed recipes can be initiated with your preferred process parameters (e.g. pressure/vacuum, agitator speed/torque, temperature, duration), thus maximising batch-after-batch reproduction while minimising human error.
Selecting the right process technology at R&D stage is crucial to ensure ultimate scale-up success. PSL’s GFD® Nutsche Filter Dryers are designed to streamline scale-up development from early R&D activities with the GFD®Lab, up to GLP batches and Pilot Plant Production using the GFD®Pilot.
It is perfectly suited to complete scale-up and scale-down studies as it helps maintain, at every scale, your key process objectives (e.g. product quality, product yield, batch consistency, etc.) and key production parameters (e.g. filtration time, washing time, drying time, etc.).
Being one of the early pioneers of containment technology, PSL has developed the unique FilterBox isolator range which can successfully accommodate every GFD®Lab vessel size (010, 050 and 500 series).
By opting for a GFD®Lab FilterBox, operators are safe-guarded from the most toxic/potent compounds and that your product is protected from production environments.
ACCORDIANS – GFD Pilot
The GFD®Pilot is an all-in-one filter dryer designed for use at pilot plant production scale. It complies with Good Laboratory Practices (GLP) and is commonly used for pharmaceutical and fine chemical processing applications. Developers and manufacturers can complete a wide range of processes in a single, standardised system:
Maximising yield is crucial at pilot scale feasibility stages and/or small-scale production. The GFD®Pilot is designed with this in mind, given the importance of the final product.
Following process completion, the product batch is collected with ease due to the design of the filtration basket which can be removed completely from the GFD® vessel.
The GFD® basket is suitable for multi-product applications as it facilitates quick and easy changeover of filtration meshes with various pore-sizes and materials such as Polypropylene, PTFE, 316LSS and Alloy 22.
The compact, mobile GFD®Pilot filter dryer provides production flexibility due to its modular design.
As with the GFD®Lab range, the base frame and motor are compatible with all relevant vessel materials (Borosilicate 3.3 Glass, 316L Stainless Steel and Alloy 22) offering a simple, fit-for-purpose solution.
The GFD®Pilot is mounted on a mobile frame to allow integration with various upstream processes.
The frame has been designed as compact as possible to allow integration within fume cupboards and walk-in laminar flow booths.
When scaling up to the operational volumes available with the GFD®Pilot, the use of organic solvents in chemical and pharmaceutical processes often means hazardous area considerations must be taken into account.
To overcome this, PSL offers alternative agitator drives suitable for such environments with appropriate certification, for example ATEX and NFPA.
Additionally, the use of pneumatic motor drives ensures the design is kept compact.
When higher operation pressures are required, metallic versions of the GFD® Pilot are available.
These are designed and manufactured in accordance with the Pressure Directives of the place of installation. PSL can deliver U-Stamp, PED and SELO certification, as required.
As one of the early pioneers of containment technology, PSL developed the unique FilterBox isolator range to accommodate all the types of vessel used with the GFD®Pilot.
By opting for a GFD®FilterBox operators are safe-guarded from the most toxic/potent compounds and the product is protected from production environments.
PSL can also provide integration packages with/for third-party containment providers.
ACCORDIANS – MSR
The MSR™ MicroSphere Refiner is a Current Good Manufacturing Practice (cGMP) piece of equipment that allows drug manufacturers to complete a wide range of aseptic processes with their microspheres at various scales. It naturally maximises product recovery, batch repeatability and production flexibility as it is capable of completing the following processes in one single system:
> Microspheres Classification/Filtration/De-watering
> Microsphere Washing
> Microspheres Drying, including Freeze-Drying
> Microsphere Sampling
> Microsphere Discharge/Recovery
The MSR™ MicroSphere Refiner is a fully automated system designed to remove manual product handling by operators throughout production. This enables maximising batch-after-batch reproducibility while minimising the risk for human error. Production can start at the touch of a button and pre-designed process recipes can be initiated.
The PSL automation platform allows drug manufacturers to pre-design and pre-load software process recipes incorporating the relevant process parameters suitable for their specific production requirements. This adds speed and flexibility to their manufacturing processes.
PSL can comply to major international practices and regulations for software automation, including GAMP5 (Good Automated Manufacturing Practice, version 5 by ISPE) and 21 CFR Part 11 established by the US FDA for electronic records and signatures.
As Microspheres are extremely valuable medicines to develop and produce it is vital that drug manufacturers maximise their product recovery in order to secure their competitive position in the global market. The core features of our MSR™ system were designed with this crucial requirement in mind.
The product recovery method of our MSR™ MicroSphere Refiner is unique as it is fully automated and it does not require any manual product off-loading by operators through an aseptic isolator, for example. Being an all-in-one solution, the MSR™ method also minimises the number of transfers and connections to aid maximising product yield.
The MSR™ is a Good Manufacturing Practice (GMP) piece of equipment, suited to multi-product applications. It is designed to allow end-users to remain agile and quickly adapt to changing production requirements.
The implementation of Process Analytical Technology (PAT) in the pharmaceutical industry is encouraged by the US FDA to ensure better product quality control and quicker time to market.
The MSR™ technology has embraced the PAT initiative as it allows drug manufacturers to complete real-time monitoring of their microsphere product quality and integrity during various production stages such as filtration and drying processes (including lyophilisation).
The integration of PAT reduces the trial-and-error approach. This helps drug companies move towards right-first-time manufacturing and reduces drug development times for microspheres – traditionally more demanding than regular drugs.
Developing complex drug formulations such as microsphere delivery systems has traditionally been challenging for most drug manufacturers, big or small. Ensuring that the chosen process technology used at R&D stage can be fully scalable to larger production batches is crucial. Finding out too late that a microsphere process is not scalable can have devastating impact and cost millions of dollars to drug manufacturers. The MSR™ product range was designed to simplify the scale-up development of microsphere drugs, from early R&D activities to GLP batches and then from clinical trials to commercial production. Our solutions can ensure that key process objectives (such as product yield, product quality and integrity, batch consistency, etc.) and key production parameters (such as filtration time, washing time, drying time, etc.) can be maintained at every scale.
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The MSR™ MicroSphere Refiner is a Current Good Manufacturing Practice (cGMP) piece of equipment that allows drug manufacturers to complete a wide range of aseptic processes with their microspheres at various scales. It naturally maximises product recovery, batch repeatability and production flexibility as it is capable of completing the following processes in one single system:
> Microspheres Classification/Filtration/De-watering
> Microsphere Washing
> Microspheres Drying, including Freeze-Drying
> Microsphere Sampling
> Microsphere Discharge/Recovery
The MSR™ MicroSphere Refiner is a fully automated system designed to remove manual product handling by operators throughout production. This enables maximising batch-after-batch reproducibility while minimising the risk for human error. Production can start at the touch of a button and pre-designed process recipes can be initiated.
The PSL automation platform allows drug manufacturers to pre-design and pre-load software process recipes incorporating the relevant process parameters suitable for their specific production requirements. This adds speed and flexibility to their manufacturing processes.
PSL can comply to major international practices and regulations for software automation, including GAMP5 (Good Automated Manufacturing Practice, version 5 by ISPE) and 21 CFR Part 11 established by the US FDA for electronic records and signatures.
As Microspheres are extremely valuable medicines to develop and produce it is vital that drug manufacturers maximise their product recovery in order to secure their competitive position in the global market. The core features of our MSR™ system were designed with this crucial requirement in mind.
The product recovery method of our MSR™ MicroSphere Refiner is unique as it is fully automated and it does not require any manual product off-loading by operators through an aseptic isolator, for example. Being an all-in-one solution, the MSR™ method also minimises the number of transfers and connections to aid maximising product yield.
The MSR™ is a Good Manufacturing Practice (GMP) piece of equipment, suited to multi-product applications. It is designed to allow end-users to remain agile and quickly adapt to changing production requirements.
The implementation of Process Analytical Technology (PAT) in the pharmaceutical industry is encouraged by the US FDA to ensure better product quality control and quicker time to market.
The MSR™ technology has embraced the PAT initiative as it allows drug manufacturers to complete real-time monitoring of their microsphere product quality and integrity during various production stages such as filtration and drying processes (including lyophilisation).
The integration of PAT reduces the trial-and-error approach. This helps drug companies move towards right-first-time manufacturing and reduces drug development times for microspheres – traditionally more demanding than regular drugs.
Developing complex drug formulations such as microsphere delivery systems has traditionally been challenging for most drug manufacturers, big or small. Ensuring that the chosen process technology used at R&D stage can be fully scalable to larger production batches is crucial. Finding out too late that a microsphere process is not scalable can have devastating impact and cost millions of dollars to drug manufacturers.
The MSR™ product range was designed to simplify the scale-up development of microsphere drugs, from early R&D activities to GLP batches and then from clinical trials to commercial production. Our solutions can ensure that key process objectives (such as product yield, product quality and integrity, batch consistency, etc.) and key production parameters (such as filtration time, washing time, drying time, etc.) can be maintained at every scale.
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As one of the early pioneers of containment technology, PSL developed the unique FilterBox isolator range to accommodate all the types of vessel used with the GFD®Pilot.
By opting for a GFD®FilterBox operators are safe-guarded from the most toxic/potent compounds and the product is protected from production environments.
PSL can also provide integration packages with/for third-party containment providers.