The injectables market is a very demanding market, with high standard requirements. i-Dositecno is offering a very high standard solution for medium and low-speed solutions with very high requirements. Our speed range covers till 9.000u/h. In this product range, we can offer maximum benefits like Isolators for high containment solutions, oRAB’s and cRAB's, IPC control with check weighing of 100% of the production, CFR 21 part 11 compliance, and smooth and accurate production.

The Ultra Pilot Lyophilizer is suitable for pilot scale work as well as small production runs. Shelf temperatures as low as -70C and condenser temperatures to -85C supports a wide range of applications.

LyoConstellation represents a brand new range of development and pilot freeze dryers, configured to order for faster delivery and specifically designed for aseptic operation. When handling high-value API, and with a need to bring product to market as quickly and safely as possible, LyoConstellation addresses early-stage development under aseptic and low particle-controlled conditions. The product therefore behaves in the same manner once it is ready for scale-up, and then commercialization. Powerful equipped as standard to provide higher capacity, broadened equipment capability, and expanded design space, LyoConstellation models S10, S20, and S30 are all equipped with the same advanced suite ofLine of Sight technologies as other SP R&D freeze dryers, providing data for full process and product life cycle management. The LyoConstellation range also fully integrates with SP filling line and semi-automatic loading systems offering best manufacturing freeze-drying practices, to achieve faster product progression from development to commercialization.

The SP Hull LyoStar 4.0 was designed and built to enhance speed to market of biopharmaceutical products and represents a significant advancement in freeze dryer engineering. Based on a full-scale production freeze dryer to support rapid-scale-up, LyoStar 4.0 is a pilot-scale lyophilizer offering superior shelf mapping, rapid shelf freezing, unmatched process accuracy and reliability. It also includes a cutting-edge suite of Process Analytical Technology (PAT) tools augmenting SP's Line of Sight™ suite of technologies which overcomes critical lyophilization challenges during development, scale‑up and manufacturing of a biologic.

Building on SP Hotpack's reputation for reliability and customer satisfaction, these stability chambers represent the ultimate in quality craftsmanship. High quality, corrosion resistant design allows for continuous use without fear of failure or downtime. Temperature and humidity are precisely controlled to meet ICH and other testing standards.

Flexible for Small Batch and High-Speed Applications
For full line vial applications that include freeze dryers, SP offers a unique row-by-row (RxR) loading system for higher-speed applications, accommodating loading speeds up to 400 vials per minute. Semi-Automatic Loading SP’s semi-automatic loading system is specifically designed for smaller batch applications that include freeze dryers.

Complete In-line Decontamination
SP Hull external vial washers are regularly used to clean the outside vial surfaces to minimize false rejects during inspection, and to clean vials filled with potent drugs. The SP range of compact in-line vial decontaminating machines includes the EVW–60 for up to 100 vials per minute, and the EVW–100 for throughputs in excess of 400 vials per minute. The EVW-100 can also have glove ports, a wash down wand and an air handling system with bag in and bag out filters to ensure sterility and containment.

The CRS, BI and LI models from SP enable processing at 200 caps per minute for aseptic applications. Crimp cappers control the vertical force during the closing operation by means of servo drives. For screw capping, torques can be monitored and recorded using a strain gauge option to increase vial protection.

Versatile and Complete Sterile Filling Solutions
SP offer a choice of machines and dispensing methods for liquid filling of oral and ophthalmic bottles, vials, syringes and cartridges. All offer the dependable sterility, accuracy and speed essential for the pharmaceutical sectors, whilst also meeting the highest quality and accuracy expectations of GMP and FDA regulations.

Fully Automatic Sterilization
There are several different methods of inactivating pyrogens, including bacterial endotoxin’s, on vial surfaces. The most common and effective way is through dry heating to above 250°C, and both manually loaded ovens for smaller batch sizes and continuous production depyrogenation tunnels have been used. SP provides a range of fully automatic sterilization/depyrogenate and tunnels for vials, in a variety of sizes including production rates in excess of 700 vials per minute. At just five feet in length, our smallest depyrogenation tunnel is ideally suited for laboratory and small batch applications.

Effective and Efficient Vial Washing
Vial washing cleans the vials of particulate matter and microorganisms; however traditional vial washers have many moving parts, which can themselves generate particulates. SP Hull vial washers have just two moving parts in their washing chamber to ensure highly effective cleaning and their main drive is servo driven. Each vial format has a Human Machine Interface (HMI) selected recipe with specific settings for spray time to help reduce water consumption. Vials are washed without the washing needle entering the vial, thereby eliminating the risk of vials being damaged due to misaligned or bent washing needles.

The Freezemobile Large Capacity Freeze Dryer is available with condenser capacities of 25 or 35 Liters. Condenser refrigeration packages of -53, -70 and -85C are available to allow configuration for a variety of solvents. A wide array of manifolds are available including stainless steel and acrylic, tree or drum manifolds, heated or unheated shelves with bulk or stoppering.

The AdVantage Pro freeze dryer with Intellitronics Controller offers users the benefit of Ethernet communication and email options. Users can monitor their cycles from anywhere they receive email. It offers the convenience of a tray dryer in a benchtop unit.

The Freezemobile Shell Bath, a floor model shell bath available in a -75C configuration, helps to decrease manifold freeze drying time. The FSB rotates the flask on its axis thereby coating the interior surface of the flask with frozen product. 

The Benchmark Freeze Dryers are custom-built production pharmaceutical lyophilizers made to meet pilot, clinical supply and production demands. Meeting your current application demands with an eye toward future demand is what we do best.

The new CharpyCool is a mechanically refrigerated bench top bath that eliminates the need for costly consumables such as liquid nitrogen or dry ice. Compact and completely self-contained, the CharpyCool offers up to 8 liters of working fluid volume enabling up to 91 Charpy impact test specimens to be accommodated at temperatures between -80°C and +30°C. A powerful variable speed magnetic stirrer and vortex breaker provide excellent temperature uniformity and stability enabling superior results. PID control enables the CharpyCool to sustain precise temperature control to within ± 0.1°C. The CharpyCool includes a digital temperature display, and an optional Charpy Rack is available which allows multiple-specimen loading and easy access to monitor your testing.

The Benchmark Freeze Dryers are custom-built production lyophilizers made to meet pilot, clinical supply and production demands. Benchmark systems are available in a wide variety of configurations and are available in economical round or space saving square tray chambers.

Hotpack glassware washers are manufactured to provide extremely accurate control and years of dependable performance. Hotpack's product line of washers meet almost any glassware washer requirement.

Designed for ease of scale-up, these models are unmatched for capabilities and performance. Designed for pilot and light production scale lyophilization, for both bulk and vial processing, these units come with an extensive list of options.

The Hull Rotary Disk valve is available as a drop-in replacement for all standard butterfly valves in 20-inch, 24-inch, 30-inch, and 36-inch sizes.

SP Genevac EZ-2 4.0 Series is the most compact high-performance sample concentrator. The fourth generation of the EZ-2 Series has been redesigned to achieve higher performance, be more user-friendly and versatile, and make far less of an environmental impact.

The miVac Duo Pump is suitable for use with a volatile organic solvents through to water, where as the miVac Quattro Pump is also suitable for use with some higher boiling point solvents. Both pumps have high flow rates to ensure the fastest possible concentration rate.

The miVac Duo is suitable for use with a wide range of solvents, from volatile organic solvents through to water for low sample numbers.

Bio-Cool Controlled-Rate Freezers feature temperatures to -40ºC or -80ºC, eliminate the use, handling, and storage of expendable high-pressure refrigerants (LN2), and Enable in-house cryopreservation capabilities to save time and money.

ThermoJet is a precision-controlled temperature forcing system that delivers an airstream of up to 20 SCFM to rapidly change the temperature of a product or Device Under Test (DUT)...

AirJet XE from FTS Systems delivers full mil-spec temperature range (­-75C to +225C) in a compact benchtop platform and runs on standard 120 volt power

Shell freezing is the classic method for preparing samples for freeze drying.

Superior corrosion resistance in a vacuum vapor trap. The Titan® Trap from FTS Systems is the first cold trap to incorporate a titanium helical coil design and Teflon coated stainless steel chamber, to provide maximum efficiency for vacuum trapping of corrosive vapors to -100C.

Chillers - Dependable cooling for laboratory applications...

The miVac DNA is an ideal small concentrator for the molecular biology laboratory. This centrifugal concentrator is capable of removing low volumes of water and organic solvents from a variety of sample formats including tubes, microplates, vials, and round bottom flasks.

Designed to dry or concentrate up to six flasks, each containing a maximum of 450ml of solvent, or 18 ASE® vials, with no user intervention or attention. The removable flask rotor may also be replaced with a 5 litre stainless steel vessel for batch processing.

Chillers - Ultra-low temperature recirculators provide maximum heat removal to -90°C...

Hotpack Under Counter Glassware Washers are engineered for durable, reliable and energy efficient operation. For laboratories with space restraints pick the Space Saver Double Stack Glassware Washer and put two Under Counter Glassware Washers together in a single vertical tower.

Mechanically Refrigerated Bath by SP Industries, Inc.

Together with our channel partners, SP operates in countries all over the globe, with a dispatch system to optimize coverage by service professionals, and immediate telephone support ready to assist you with your SP products. We have also introduced innovative features such as Google glasses for some product lines to allow remote and real time, technical guidance and troubleshooting by video.

Robot filling and plungering machine for glass and plastic syringes, cartridges and vials in nest up to 6000 u/h with 2 nozzles, 12000 u/h with 5 nozzles and 24000 u/h with 10 nozzles. The syringe filler is compatible with RABs or isolator enclosures. The system is able to work with stainless steel or ceramic rotary piston pumps or peristaltic pumps with possible standard filling with mechanical plunger introduction or vacuum plunger introduction. Automatic nest unloading and loading of tubes. The cleanroom style robot is used to position syringes for filling and stoppering. Manual or semi-automatic debagging, manual, semi-automatic or automatic delidding are available along with 21 CFR Part 11 and audit trail capabilities.

Linear filling, stoppering/tip placement/pump inserting and crimping or closing machine for bottles and vials up to 12,000 u/h. This system is compatible with RABs or isolator enclosures. The system is able to work with stainless steel or ceramic rotary piston pumps or peristaltic pumps. Systems are available for manual or semi-automatic debagging, manual, semi-automatic or automatic delidding for pre-sterilized glass as well as cleanroom unscrambler’s for ophthalmic containers. Systems are 21 CFR Part 11 and audit trail compatible.

Rotary filling, stoppering/tip placement/pump inserting and crimping or closing machine for bottles and vials up to 6000 u/h. The system is compatible with RABs or isolator enclosures. The system is able to work with stainless steel or ceramic rotary piston pumps or peristaltic pumps. Systems are available for manual or semi-automatic debagging, manual, semi-automatic or automatic delidding for pre-sterilized glass as well as cleanroom unscrambler’s for ophthalmic containers. Systems are 21 CFR Part 11 and audit trail compatible.

Filling and capping machine for eye-drop bottles.

Ecodyst® is the global leader and creator of the next generation of rotary evaporators used by scientists in pharmaceutical, cannabis and other industries, either in research or commercial settings. Using a proprietary and innovative self-cooling technology, Ecodyst has evolved the EcoChyll® evaporators to be more efficient, have a smaller footprint, and be less costly to operate than traditional methods. The range consists of benchtop and industrial scale evaporators to accommodate many applications. This disruptive technology has set new standards worldwide for scientific instruments.

Designed to dry or concentrate up to six flasks, each containing a maximum of 450ml of solvent, or 18 ASE® vials, with no user intervention or attention. The removable flask rotor may also be replaced with a 5 litre stainless steel vessel for batch processing.

SP Genevac EZ-2 4.0 Series is the most compact high-performance sample concentrator. The fourth generation of the EZ-2 Series has been redesigned to achieve higher performance, be more user-friendly and versatile, and make far less of an environmental impact.

The miVac DNA is an ideal small concentrator for the molecular biology laboratory. This centrifugal concentrator is capable of removing low volumes of water and organic solvents from a variety of sample formats including tubes, microplates, vials, and round bottom flasks.

SP Genevac HT Series 3i Evaporators are the ideal solution for parallel evaporation bottlenecks in high throughput and production laboratories having high performance and high sample capacities.

Rotary filler for clinical and early-stage pharma production specialized for fill finish advanced aseptic manufacturing for pharmaceutical and biologics injectables. Designed to be used in an isolator.

Full-line solutions right through to packaged pharmaceutical products - with equipment you can rely on, no matter your scale.  Automated, cleanroom-ready solutions comply with industry regulations, reduce human interface and risk, while maximizing production and profitability.

Automatic Loading/Unloading Systems can be installed as part of a new freeze dryer installation and as retrofit with almost all existing freeze dryers.

The TL-100 is controlled by a Programmable Logic Controller (PLC) and will handle plastic and glass vials with speeds of up to 200 vials per minute (depending on vial diameter and tray size). It is designed to handle trays up to 610 mm (24") wide (open end) and up to 610 mm (24") deep. Tray materials can be metal, cardboard, corrugated plastic, or rigid plastic.

The TL-200 has two loading platforms (the TL-100 has one), so that two trays are loaded simultaneously. Once the trays are full, the operator replaces one of the loaded trays with an empty one and the machine immediately resumes loading that tray. The operator then replaces the other loaded tray with an empty one. When in place, the machine will resume loading both trays. The process is seamless; there is no additional work to be done or buttons to be depressed by the operator. Once a tray is full, the loading process stops and a yellow light and audible signal indicate that the tray can be replaced.

PennTech manufactures an array of standard and custom sanitary conveyors and accumulation tables, including transfer disks. All systems are of the highest quality, completely customizable and direct driven (zero maintenance).