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Maker - Product Challenge

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Pharmaceutical R&D Equipment

Innovators in the highly regulated and highly dynamic pharmaceutical market place need equipment that is worry-free and flexible enough to vary products and process variables as new products are developed.  Laboratory capsule filling machine must be easy to maintain, allow for rapid tooling change-over, and provide tightly controlled process variables and automatic operation in order to ensure results that are reproducible at the production scale.


<h2>A complete encapsulation solution for the laboratory</h2>
The AFT-T Lab system from ACGE is a laboratory capsule filler from the AF series of capsule fillers that is currently running in over 1000 production facilities throughout the world.  The AF series of machines is built for regulatory compliance, revenue optimization, and flexibility giving pharmaceutical manufacturers the features they demand such as formulation and dosing control, minimal product loss, a wide range of peripheral equipment, and globally available support.

The AFT-T Lab machine has all the benefits associated with the larger equipment in the series but on a scale appropriate for laboratories.  The machine can output up to 6,000 capsules per hour for powder filling and 5,000 capsules per hour for pellet filling.  It uses a 1.1 kW primary motor.  It weighs about 1,200 Kg and occupies only 2.25 square meters of floor space making it the perfect scale for any pharmaceutical laboratory.

Automatic laboratory capsule filler

Particularly suitable for research centers requiring greater freeze drying capacity. Some of the most common applications are galenic formulation, freeze drying experimentation, aliquot preservation, taxidermy, experimental food and so on.


<h2>The laboratory freeze dryer that is easy-to-use</h2>
The LyoAlfa from Telstar Life-Sciences is a compact laboratory freeze dryer. It comes as a console and is mounted on casters which make it easy to install. The unit is very flexible, allowing for the simultaneous freeze drying of bottles, vials or bulk products through the connection of different manifold systems or a chamber.

It is available in two models LyoAlfa 6 -50, with a final condenser temperature of -50 ºC; and LyoAlfa 6 -80, with a final condenser temperature of -80 ºC. This enables a higher freeze drying speed and is much more suitable for working with biological samples or products with very low eutectic or collapse points.

Compact laboratory freeze dryer

<span style="font-weight: 400;">For laboratory pharmaceutical R&amp;D work or use in clinical trials, a high-accuracy small-scale benchtop weight sorter is the perfect solution. However, small size should not limit flexibility, and a benchtop machine able to handle a full range of tablet and capsules saves cost and improves efficiency.</span>
<h2>Fully flexible and high accuracy weight sorter scaled for the lab</h2>
<span style="font-weight: 400;">The SADE SP-B40 from CI Precision is a highly accurate, easy to operate and fully flexible solid dosage weight sorter for use in laboratory environments. Designed to be very easy to operate, product is simply loaded into the bowl feeder and then automatically weight-sorted to an accuracy of +/- 1mg. The unit can also be configured to offer accuracy of +/-0.5mg for situations that require even more precision. Like the other members of the SADE family, the SP-B40 can handle tablet sizes up to 20mm x 24mm, and capsules from 5 through to 00 size (larger sizes may be accommodated).</span>

<span style="font-weight: 400;">Offering even more flexibility and value, as well as weight sorting the machine can be quickly and easily configured into quantity sorting mode. This makes it perfect for filling bottles or other containers with the exact number of doses required every time - particularly useful in clinical trial situations. The unit records all operations and can send reports direct to a printer or via a PC interface.</span>

<span style="font-weight: 400;">As well as saving time by eliminating the need for manual sorting and operating at up to 75 units per minute, the SP-B40 is also quick and easy to clean down, and its GMP design means all contact surfaces are either stainless steel or PEEK.</span>

Benchtop weight sorter for tablets &amp; capsules

Users who prefer rigid storage over single-use pharma charge bags, require lightweight solutions for easy handling, especially when storing and transferring active pharmaceutical ingredients. The containers must clamp securely to equipment to ensure no powder loss or cross-contamination and make efficient use of space when stored.
<h2>Bottles for Convenient Storage and API Powder Transfer</h2>
Ezi-Dock pharma process bottles were designed to be used with Split Butterfly Valves. They have unique square design ensuring a more compact footprint per unit of storage in pharmaceutical and biopharmaceutical laboratories. Their filling and dispensing necks feature a standard 6-inch Tri-Clamp neck design that uses an injection-moulded adaptor to connect to laboratory equipment receiving the product.

These versatile containers are available in a variety of sizes including 15, 25, 30 and 40 litre capacity. Bottles are in individual cartons packed in quantities of 84, 60, 48, and 36 respectively for space-efficient storage. They are made of high-density polyethylene that is blow-moulded to comply with the U.S. Pharmacopeia standard.

API powders storage bottle

A Laboratory air jet sieve is used for determining the particle size distribution of powdery and granular materials.


<h2>Intuitive analysis of particle size distribution</h2>
The e200 LS from Hosokawa is ideal for analyzing any kind of dry material. Samples of between 0.3 and 100 grams in weight can be analyzed easily and quickly. The batch weight is dependent on the sieve mesh width and material density. The extraordinarily good dispersion of the material being analyzed by the nozzle jet permits analyses down to 10 µm with the micro-precision sieves.

The only thing that moves the material being analyzed is the airflow. This system makes it possible to do without any and all mechanical means of influencing the sieving process of different materials, such as non-organic or organic granular materials including sands, crushed rock, clays, granite, feldspars, coal, soil, a wide range of manufactured powders.

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Laboratory air jet sieve

A laboratory fine impact mill is used for fine and ultrafine grinding, for defibration, and for cutting soft materials.


<h2>Small scale size reduction of soft materials</h2>
The 100 UPZ und 160 UPZ Fine Impact Mills from Hosokawa Alpine are designed for fine and ultrafine grinding, for defibration, and for cutting materials of Mohs' hardness up to 3. Depending on the equipment, powder fineness values range from approx. 100 µm to 1500 µm.

The fine of the final product is adjusted by the selection of the corresponding size reduction elements and as a function of the machine speed.

This mill has many applications in the chemical industry, foodstuffs, and animal feed industry as well as in the pharmaceutical industry.

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Laboratory fine impact mill

HEPA filtered horizontal laminar airflow (cross-flow) creates an optimized free space for manipulation with ISO 14644-1 (Class 5) conditions.


<h2>Compact booth that offers easy access to manipulate non-hazardous products</h2>
Mini-H from Telstar Life-Science are Horizontal laminar flow benches which offer the highest product protection versus dust and contamination in an open cabinet for non-hazardous samples such as cell and tissue cultures, food testing preparation, injectable medicine preparation. It also fits for micromechanics, optics and electronics.

The Compact horizontal laminar flow bench comes with HEPA filtered air; it's particle free and flushes the product preparation space with laminar flow, preventing direct or cross-contamination.

Thanks to its very compact size, Telstar Mini-H permits the installation of a product protection cabinet near the place where the product is utilized.

Compact horizontal laminar flow bench

Pharmaceutical R&amp;D and laboratory extrusion of viscous hot melt masses requires a GMP design, FDA approved cooler that meets the highest demands of industry whilst being compact and easy to use for small batch production.


<h2>Small batch and laboratory GMP hot melt extrusion cooler</h2>
The BBA Innova CCR-20/12-PH is an innovative cooler using Chilled Cooling Rolls technology to solidify product after passing through a hot melt extruder, which is then passed to a built-in flaker.

Designed specifically for small scale and lab pharmaceutical operation, the CCR-20/12-PH is compact, portable and easy to set and use. Suitable for GMP environments thanks to the complete separation of drive and processing sections, the unit has been designed to be easy to clean to the highest required standards for pharma applications.

All-FDA approved materials are used throughout and product contacting components are all removable simply, without the need for tools.

With a maximum throughput of 10kg per hour, this unit is ideal for testing and for small batch production. All parameters that have been used in testing can be directly upscaled to the production version cooler, making this part of the ideal combination for R&amp;D.
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Laboratory GMP cooler for hot melt extrusion

A recent important change in the industry is the trend toward providing liquid doses contained in hard capsules.  The right equipment is need to develop processes to fill hard capsules with the wide variety of liquids used by today's pharmaceutical producers.  Laboratory equipment that is capable of handling waxes and lipids, automatically sealing the capsules, and maintaining a tightly controlled process suitable for scaling to production levels will give pharmaceutical innovators an edge of the competition.


<h2>Fill and seal hard capsules with any pharmaceutical liquid</h2>
Fluidocap 1000 is a semi-automatic machine for filling hard pharmaceutical capsules with liquid an sealing them.  It is provided by ACGE-Associated Capsules a world leader in pharmaceutical machinery manufacturing.  Traditionally liquid doses have been provided in soft gel-cap form and have presented drug makers with the common problems of high cost, wastage, cross contamination, migration of the drug into the capsule, and low bioavailability.

The Fluidocap range of machines address these issues by allowing the filling and sealing of hard capsules with liquid compounds rather that relying on soft gelcaps.  The hard capsules can be filled with a wide range of formulations including lipid-based products, high viscosity pastes, and wax type products.  They are sealed with a gelatin band.  The Fluidocap 1000 capsule filler for liquid is designed for laboratory use and can produce up to 1000 capsules per hour but can easily be scaled up to commercial level production.

Laboratory capsule filler for liquid solutions

A laboratory conical screw mixer is often used in the pharmaceuticals and fine chemicals sectors, in order to investigate or create new compounds. When a gentle mixing action is needed, the low shear agitation results in minimal mechanical product stress and is therefore particularly suitable for homogenizing sensitive bulk powders and solids with very different product characteristics.


<h2>Reliable predictions from only 0.3 liters powder contents</h2>
The Vrieco-Nauta® Minimix lab mixer is a 3-liter conical screw mixer from Hosokawa Micron and has the same advantages as the production size Hosokawa Vrieco-Nauta mixer: High mixing accuracy, gentle mixing, complete discharge and flexible filling range. Already giving reliable predictions from only 0.3 liters powder contents, specially designed for segregative, free-flowing powders and pastes in a batch process. Suitable for a wide range of processing activities in the pharmaceutical, food, plastic, metals &amp; minerals, nuclear, chemical, pigments and coatings industries.

Laboratory conical screw mixer

Specially designed for the handling of microbiological agents, when working with indigenous or exotic pathogenic agents that pose a moderately high risk of serious or potentially lethal disease to the operator when inhaled.


<h2>Offering Class III biological safety to operator, product and environment</h2>
The Biological safety cabinet class III from Telstar Life-Science is a laboratory isolator designed according EN 12469, offering an ergonomically designed totally sealed which keep the user completely separated from the product by a physical barrier when total containment and user protection is required.

Series MSC III is a completely gastight cabinet. The dangerous biological agents enter the work area by a hatch, the operator uses gloves (assembled to the front of the cabinet) to research the biological agents. While working, potential contaminated air is controlled by airflow and negative air pressure.

Biological safety cabinet class III

Freeze dryer designed for aseptic and small-scale production of high-value products.


<h2>Industrial freeze dryer in a compact envelope</h2>
Lyotris from Telstar Life-Sciences is a lab scale production freeze dryer designed for the production of small batches of high-value pharmaceutical products. With a 1m2 loading surface and capacity for approximately 1,600 10R-type vials or 30 liters of bulk product. It has been specially designed for aseptic production in vials or in bulk and its novel fascia and door design provides easy isolator integration.

The GMP laboratory freeze dryer comes with all  the necessary components for an automatic cleaning (CIP) and steam sterilization (SIP) processes, filter integrity testing (WIT) and also incorporates an advanced SCADA system which includes Telstar's patented ‘Lyometrics' system; providing advanced real-time information on the freeze-drying process.

GMP laboratory freeze dryer

<span style="font-weight: 400;">Offering lab-scale to small pharmaceutical production scale output for in one unit means maximum cost-benefit when acquiring a homogenizer. Capable of achieving a range of processes including cell disruption, particle size reduction, creating stable nano/micro emulsions and working with polymers and liposomes, this benchtop scale unit can operate at up to 15 litres per hour capacity, yet still offer lab quality results.</span>
<h2>Air-operated, compact, bench-top homogenizer suitable for a broad range of applications</h2>
<span style="font-weight: 400;">The Micro DeBEE from BEE International is a compact, laboratory-scale homogenizer that can also be used for small-scale production. This is an air-powered unit that can process as little as a single 5ml sample, up to as much as 15L per hour, offering exceptional flexibility.</span>

<span style="font-weight: 400;">Features that make it an excellent R&amp;D machine include maximum pressure of 45,000 PSI/3100 bar (at 150 PSI, 55 CFM). In addition, the back pressure can reach 5,000 PSI/350 bar, but this is adjustable to your specific process.</span>

Micro DeBEE is simple in operating, and exceptionally easy to maintain and clean (with no disassembly required), adding further to the value proposition.

High pressure air powered laboratory homogenizer

<span style="font-weight: 400;">It’s vital that small units for experimentation can scale up with 100% accuracy. Ease of use, reliability and simple maintenance means increased work efficiency, and rapid cleaning and suitability for sanitary uses increase flexibility and improve return on investment.</span>
<h2>Cost-effective benchtop homogenizer with reliable and consistent process for R&amp;D</h2>
<span style="font-weight: 400;">The Nano DeBEE from BEE International is a market-leader in laboratory-scale homogenizers. Designed for maximum flexibility, the Nano DeBEE can be used for a range of procedures including cell disruption, particle size reduction, nano/micro emulsions and nano/micro dispersions. Despite the minimum sample size of only 5ml, the results obtained from the DeBEE are guaranteed 100% scalable to production processes.</span>

<span style="font-weight: 400;">Offering excellent value for money, the Nano DeBEE can operate at up to 45,000 PSI of pressure and yet it is simple to clean and maintain and it’s suitable for sanitary applications where required. A further major benefit is that DeBEE will provide new staff training for the lifetime of the product.</span>

High pressure electric laboratory homogenizer

Products can be extruded with a variety of shapes and characteristics by controlling the nozzle geometry and pressure and temperature characteristics of substrates as they are propelled through a screw style mixing machine. Precise control of pressure at the point of extrusion is essential to predictable, desirable results.


<h2>Small scale, precisely controlled extrusion of animal feed</h2>
Amandus Kahl’s Extruder OE 8 is a small batch or laboratory extruder that works on the same principal as the successful Annular gap expander design where a conical stop is used to restrict flow out of a tube as materials are driven through it by a rotating shaft. The stop is moved towards and away from the tube creating an adjustable sized gap through which material leaves the tube. Controlling the size of this gap relative to the material throughput determines the pressure under which the material is extruded and influences many of the product’s final characteristics.

These units can be provided with heating or cooling jackets and provisions for monitoring temperature and pressure. Precisely controlled product extrusion is thus achieved by applying Amandus Kahl’s patented gap control technology from the annular gap expanders to this simpler machine.

Laboratory extruder

<span style="font-weight: 400;">Automated pressing of tablets saves time and improves quality. In R&amp;D or laboratory environments a dedicated minimal form factor tablet press provides maximum flexibility for the production of smaller batch sizes.</span>
<h2>Plug-and-play tablet press designed for lab and R&amp;D environments</h2>
<span style="font-weight: 400;">The Sejong Pharmatech P130S has been designed from the ground up as a lab-scale tablet press, and offers features that make it extremely flexible in pharmaceutical R&amp;D.</span>

<span style="font-weight: 400;">Available in 3 models offering 9,600, 19,200 and 24,300 units per hour, the P130S is capable of producing both round or oblong tablets up to 25mm across and up to 8.5mm in depth, allowing for a wide variety of sizes.</span>

<span style="font-weight: 400;">The unit has a mechanical bar and round type feeder and offers full automatic weight control (AWC) for the rejection of any faulty tablets, removing the need for manual intervention for quality control.</span>

<span style="font-weight: 400;">Featuring a full touch screen interface, the P130S makes it easy for operators to control all aspects of the machine’s function via a graphical HMI. The control system features full 21CFR part 11 reporting compatibility, offering simple regulatory compliance.</span>

Lab scale single layer tablet press

Research and development (R&amp;D) is vital to ensure you maintain your competitive advantage, and it’s important not only to explore new products and processes, but also to continually improve existing products. Pharmaceutical R&amp;D machines and equipment must replicate the processes involved in full-scale production to allow for accurate trial or test results, yet they must have a form-factor and footprint that is more suitable for lab work or for use in smaller development lines. R&amp;D equipment should be able to handle small batch sizes, and yet be able to scale up production results accurately, allowing full analysis and product quality metering.

Find lab scale R&D solutions for production pharmaceuticals and connect directly with leading machine and equipment manufacturers world wide.