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.
ACCORDIANS – ANFD
PSL’s Agitated Nutsche Filter Dryers are an all-in-one piece of equipment designed to comply with Good Manufacturing Practices (GMP) for regulated development and production activities. They allow process developers and manufacturers to complete a wide range of processes into one single system
> Slurry Filtration
> Product Washing
> Re-slurry
> Vacuum Drying
> Product Sampling
> Product Discharge
PSL’s strength lies in our comprehensive knowledge of the GMP regulations combined with our practical experience and knowledge of a wide range of manufacturing workflows.
Our PSL filter-dryers provide optimum levels of safety and quality and can be manufactured to comply with various industry practices (cGMP, GAMP, etc.), directives (ATEX, etc.), regulations (21 CFR Part 11, etc.) and initiatives (PAT, etc.) from industry regulators such as the FDA.
Over the last three decades PSL has earned the trust of our industry partners by delivering precision-built containment solutions to protect the health of their workforce.
Numerous industrial filtration and drying processes require to integrate containment technology in order to protect operators from highly toxic compounds and/or to protect sensitive products from a harmful production environment.
Our high containment systems guarantee operator protection and operate under negative pressure HEPA-filtered atmosphere. PSL isolators have been used globally to process highly potent compounds requiring extremely low Occupational Exposure Limit (OEL) such as 20ng/m3. These compounds can include High Potency Active Pharmaceutical Ingredients (HPAPI), cytotoxic and other hazardous substances.
Our containment solutions adapt to individual company needs either through rigid or flexible/disposable containment solutions.
PSL gloveboxes can be manufactured to comply with industry practices (cGMP, GAMP, etc.), directives (ATEX, etc.), regulations (21 CFR Part 11, etc.) and initiatives (PAT, etc.).
Selecting the right processing technology is critical to scaling up your process and ensuring production success.
Our renowned filtration and drying range is globally recognised to streamline the most complex scale-up process developments, from early R&D activities to GLP batches, pilot plant and ultimately GMP commercial production.
Our filter-dryer portfolio will allow you to perform scale-up and scale-down studies and maintain – at every scale – your various process objectives (e.g. product quality, product yield, batch consistency, etc.) and production parameters (e.g. filtration time, washing time, drying time, etc.).
Kilo Laboratory
Pilot Plant
Commercial Production
At PSL, we understand that your product is extremely valuable and that you must maximise your production yield in order to remain competitive in your market. The core features of our filter-dryers were designed keeping this crucial requirement in mind.
Upon process completion inside a PSL nutsche filter dryer, your valuable product can be recovered very simply by utilising the PSL agitator to automate the discharge process. Subsequently, the remainder of your batch – also called product heel – can be collected following the ‘’Direct Heel Recovery’’ method originally pioneered by PSL in the industry several decades ago.
This method has proven to be the most efficient for high yield productivity and it consists of manually raking the product heel into a PSL high containment off-loading glovebox (ergonomically designed and integrated by PSL). Thus ensuring a full product recovery under safe conditions for your operators, product and environment.
ACCORDIANS – SimpleFilter
The SimpleFilter™ is designed to allow process developers and manufacturers to complete a wide range of processes into one single system, hence maximising production efficiency and reducing equipment footprint.
> Slurry Filtration
> Product Washing
> Re-slurry (optional agitator recommended)
> Vacuum Drying
> Product Sampling
> Product Disharge
The SimpleFilter™ is a GMP piece of equipment ideal for multi-product applications. It is designed to allow end-users to remain agile and to quickly adapt to changing production requirements.
At Powder Systems, we understand that selecting the right processing technology is critical to scale-up your process and ensure your ultimate production success. The core features of our SimpleFilter™ were designed keeping this crucial requirement in mind.
Upon batch completion inside the SimpleFilter™, your product can be easily collected by manually raking your batch from the vessel side-discharge into the glove-bag. If the agitator upgrade is purchased, the batch discharge process can be automated, with the final product heel removal only remaining manual.
Our SimpleFilter™ product range was designed to streamline your scale-up development, from feasibility studies to pilot plant and commercial production. It the perfect tool to complete scale-up and scale-down studies as it will help you maintain – at every scale – your key process objectives (product quality, product yield, batch consistency, etc.) and key production parameters (filtration time, washing time, drying time, etc.).
Being one of the early pioneers of containment technology, PSL has made all of its SimpleFilter™ models compatible with contained discharge technology.
The unique PSL glove-bag containment system was developed to allow end-users to perform safe product sampling and discharge within a nitrogen purge atmosphere for additional process safety and product integrity assurance.
Each flexible glove-bag is equipped with a 2-glove arrangement to enhance ergonomics and maximise product recovery by allowing product heel-removal. A tri-clamp connection is also provided to connect the glove-bag to the chosen discharge container (via continuous liner system, split-butterfly valve, etc.)
ACCORDIANS – LabMSR
The purpose of the LabMSR™ is to provide R&D staff with an innovative tool enabling them to complete reliable product scale-up activities and refine their process parameters while being in a laboratory environment. The LabMSR™ will allow its end-users to reproduce the following processes, in particular:
> Microspheres Classification/Filtration/De-watering)
> Microsphere Washing
> Microspheres Drying, including Freeze-Drying
> Microsphere Discharge/Recovery
** Whilst the LabMSR™ vessel can be steamed-in-place, its design is uniquely developed for laboratory activities and is not recommended for commercial batch production.
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 or pilot 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 LabMSR™ is the ideal solution to bridge the gap between your early R&D development activities and your GMP clinical batch production. This unique technology was developed by PSL to put your scale-up development on autopilot and to ensure that your 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.
Microspheres are extremely valuable medicines to develop and produce. Every drug manufacturer has the imperative to maximise their product recovery in order to secure their competitive position in the global market. The core features of our LabMSR™ system were designed keeping this crucial requirement in mind.
As per our MSR™ MicroSphere Refiner for GMP production, the product recovery method used by our LabMSR™ is completed by tilting the vessel. Being an all-in-one solution, the LabMSR™ method also minimises the number of transfers and connections, hence naturally maximising product yield.
The LabMSR™ is suitable for multi-product applications and is the ideal tool to develop a wide range of microsphere drugs. It was designed to allow manufacturers to develop their drug pipeline by remaining agile and adaptable to ever-changing production requirements.
The implementation of the Process Analytical Technology (PAT) initiative in the pharmaceutical industry has been encouraged by the US FDA in order to ensure better product quality control and quicker time to market.
The LabMSR™ 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 need for trial and error and helps drug companies towards right-first-time manufacturing, hence reducing drug development times for microspheres – traditionally more tedious than regular drugs.
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The purpose of the LabMSR™ is to provide R&D staff with an innovative tool enabling them to complete reliable product scale-up activities and refine their process parameters while being in a laboratory environment. The LabMSR™ will allow its end-users to reproduce the following processes, in particular:
> Microspheres Classification/Filtration/De-watering)
> Microsphere Washing
> Microspheres Drying, including Freeze-Drying
> Microsphere Discharge/Recovery
** Whilst the LabMSR™ vessel can be steamed-in-place, its design is uniquely developed for laboratory activities and is not recommended for commercial batch production.
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 or pilot 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 LabMSR™ is the ideal solution to bridge the gap between your early R&D development activities and your GMP clinical batch production. This unique technology was developed by PSL to put your scale-up development on autopilot and to ensure that your 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.
Microspheres are extremely valuable medicines to develop and produce. Every drug manufacturer has the imperative to maximise their product recovery in order to secure their competitive position in the global market. The core features of our LabMSR™ system were designed keeping this crucial requirement in mind.
As per our MSR™ MicroSphere Refiner for GMP production, the product recovery method used by our LabMSR™ is completed by tilting the vessel. Being an all-in-one solution, the LabMSR™ method also minimises the number of transfers and connections, hence naturally maximising product yield.
The implementation of the Process Analytical Technology (PAT) initiative in the pharmaceutical industry has been encouraged by the US FDA in order to ensure better product quality control and quicker time to market.
The LabMSR™ 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 need for trial and error and helps drug companies towards right-first-time manufacturing, hence reducing drug development times for microspheres – traditionally more tedious than regular drugs.
The LabMSR™ is suitable for multi-product applications and is the ideal tool to develop a wide range of microsphere drugs. It was designed to allow manufacturers to develop their drug pipeline by remaining agile and adaptable to ever-changing production requirements.
The SimpleFilter™ is designed to allow process developers and manufacturers to complete a wide range of processes into one single system, hence maximising production efficiency and reducing equipment footprint.
> Slurry Filtration
> Product Washing
> Re-slurry (optional agitator recommended)
> Vacuum Drying
> Product Sampling
> Product Disharge
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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.