Rotary Vial Washers

Range of low maintenance washers for low to high throughput manufacturing, guaranteed to reduce particulates by 1000 times.

Sterilising Tunnels

Fully automatic sterilising tunnels for continuous aseptic processing of vials, syringes and ampules

Fillers and Stoppering

Filling equipment capable of volumes ranging from 100 μL to 500 mL at up to 200 vials per minute.

Capping Machines

For aseptic as well as oral applications, offering dependable vial protection at speeds of 200 caps per minute.

External Vial Washers and Trayloaders

Single and dual station tray loaders to support speeds of 200 to 500 vials per minute with freeze dryers and freeze dryer loading systems.

Aseptic Processing Trends

To discover current Aseptic Processing Trends click the button below download the brochure:

Rotary Vial Washers

Benefits

Dependably effective washing: Guaranteed reduction of particles by 1000 times and spray manifold eliminates the risk of chipping vials

Suitable for almost any manufacturing space: Small footprint and reduced water usage

Highly efficient and economical to run: Simple servodriven operation with fewer moving parts reduces maintenance and dedicated recipes, to ensure vastly reduced water usage

Extremely flexible: Easy and quick change between different sizes of glass or plastic vials

RW-250

Minimal footprint, semi-automatic rotary vial washer for 2-100ml glass or plastic vials with up to 70 vials p/min output

rw-500

RW-500

Automatic rotary vial washer for pharmaceutical and biotech applications with output up to 120 vials p/min

RW-800

Medium speed automatic rotary vial washer for vials 2-250ml with output of up to 200 vials p/min

RW-1150

High-speed automatic rotary vial washer with output of up to 400 vials p/min for pharmaceutical and biotech applications

The RW series of rotary vial washers are designed to be an efficient means of particulate matter and microorganism removal, an alternative to labour-intensive, batch-style vial washers. By minimising the number of moving parts (such as grippers with springs, penetrating spray needles and chains), the user-friendly RW series offers minimal operator requirement and maintenance.

With minimal footprint, and the capability to recycle, filter and re-use WFI, the range can cover the full range of pharmaceutical vials (2-100 mL) with efficiency in mind. Each vial formal has an HMI selected “recipe”, with specific settings for a variable such as spraying time and indexing time.

Sterilising Tunnels

Benefits

Highly effective sterilisation: Guaranteed thermic cycle regardless of pressure fluctuations

Efficient automatic processing: Fully automatic, continuous aseptic processing offers increased efficiency for batch processing

All manufacturing requirements: Modules available for small and large batch sizes

These laminar airflow tunnels are designed to continuously and efficiently sterilise and depyrogenate pharmaceutical glass containers, in a Class 100 environment at 320ºC. At this temperature, it takes only 9.5 seconds to reduce the bacterial endotoxin level by 1-log. A 4-log reduction will take 38 seconds, whilst a 6-log reduction will take 57 seconds.

Heat is generated by silicon controlled rectifier elements. Depending on the format vials stay inside the sterilising chamber for approximately 6-10 minutes. The recirculated hot air is blown at a speed of approximately 0.7m/s over the vials, and remains within 2°C of its setpoint. SP i-Dositecno sterilising tunnels are fully compatible with SP i-Dositecno vial handling solutions and trayloaders and can be integrated into other existing or new installations.

  • Dimensions
    Varies depending on the model
  • Purpose
    Fully automatic sterilization/depyrogenation tunnels for vials, syringes and ampules
  • Vial Range
    2-100ml
  • Output
    Varies depending on the model
  • Changeover
    Varies depending on the model

– In fewer than 30 minutes, an untreated vial goes from vial washer to sterilising tunnel to cleanroom, entering in a sterilized microorganism- and pyrogen-free state
– Requires no operator intervention or recontamination
– Typical operating temperature of the tunnel is 320°C
– At this temperature:
– It takes 9.5 seconds to reduce the bacterial endotoxin level by 1-log
– A 4-log reduction will take 38 seconds
– A 6-log reduction in bacterial endotoxin 57 seconds
– Heat is generated by silicon controlled rectifier (SCR) heating elements
– Depending on the format, vials stay inside the sterilizing/depyrogenation chamber for approximately 6-10 minutes
– The recirculated hot air is blown at a speed of approximately 0.7 m/s over the vials and remains within 2°C of its setpoint
– Keeping control over the vials at all times, vials are fed from the vial washer via a sanitary conveyor before gently being pushed into the tunnel by an oscillating pusher
– No format parts are required
– This is essentially a set-it-and-forget-it automatic process
– There are 3 chambers: pre-heating chamber, sterilising chamber, cooling chamber
– Chambers of the tunnel are separated by gates and the height is automatically set by the PLC as part of the vial recipe
– HEPA filters are tested for efficiency by the “DOP” test procedure (each chamber of the tunnel has provisions to conduct the DOP)
– Each chamber is equipped with a pipe below the filters to allow for particle counting

Fillers and Stoppering

Benefits

Ideal for containment and sterility: Compatible with Restricted Access Barriers (RABs) or isolator enclosures

Exceptionally flexible: Available for manual or semi-automatic de-bagging and de-lidding for pre-sterilized glass as well as cleanroom unscrambler’s for ophthalmic containers

Compliant with manufacturing regulations: 21 CFR Part 11 and audit trail capable

LI Linear Fillers

BI Rotary Fillers

SY Syringe Fillers

The SY, BI & LI series is a line of filling equipment for injectables, oral, ophthalmics, syringes and cartridges. Vial filling up to 200 vials per minute. The Aseptic filling series is made up of multiple models to cover a wide range of applications for the pharmaceutical industry. The fillers and cappers are an integral part of our full line solution.

Sterile Filling Systems

Biopharma Group partner – SP Scientific and Lab i-DOSiTECNO Pharma Technologies (Barcelona, Spain) recently joined forces to become SP i-Dositecno enabling both companies to offer complete aseptic vial and syringe fill-finish lines. This new partnership brings together the freeze drying and vial washing/sterilising technologies from  SP Scientific, with the advanced and comprehensive vial and syringe filling capabilities of Lab i-DOSiTECNO to offer a complete end-to-end sterile filling solution.

SP i-Dositecno offers the market advanced, high-quality solutions for sterile filling systems including ophthalmic and injectable processing lines. All sterile machines are manufactured using materials of the highest standard to achieve maximum quality, effectiveness and accuracy.

Systems for injectables have been developed to fill vials and syringes covering a large range of products from 0.1ml to 500ml in vials and 0.1ml in syringes to 20ml. For ophthalmic solutions, we offer options to handle bottle sizes up to 500ml, including standard eye-droppers and screw capping styles, to systems like the new Aptar filtered cap.

Filling systems start from peristaltic pumps to complex ceramic rotary pumps with integrated CIP/SIP system. These sterile filling solutions are offered with a high specification software that is compliant to CFR21 part 11, track and trace control, and IPC control (Inline Process Control). All machines can be isolated which is ideal for biotechnology projects too.

o series

Sterile Ophthalmics

Sterile Injectables

To discover more about our latest i-Dositecno range and how it enhances the SP aseptic processing line range for complete vial handling and freeze drying solutions, download the brand new booklet from SP i-Dositecno here:

Capping Machines

Benefits

Compact design: Suitable for almost all manufacturing facilities

Dependable vial protection: Vertical force control during cap crimping and torque control/strain gauge feedback for screw capping applications

Ideal for containment and sterility: Compatible with Restricted Access Barriers (RABs) or isolator enclosures

Compliant with manufacturing regulations: 21 CFR Part 11 and audit trail capable

Models LI-C & CRS-200

The CRS (continuous rotary) & LI (linear) motion capping models offer closing/ capping solutions for aseptic injectable, oral, nasal spray and opthalmic applications up to 200 cpm (cappings per minute). These sytems can be integrated with a vial washer, depyrogenation (sterilising) tunnel, filling/stoppering machine, freeze dryer and freeze dryer loading systems, external vial washers and tray loaders to provide an integrated full line solution. Machines are compatible with RABs or isolator enclosures.

Crimp cappers control vertical force during the closing operation by means of servo drives. For screw cap applications, application torques can be monitored and recorded using a strain gauge option.

Systems are 21 CFR Part 11, audit trail capable and feature a stainless steel construction with tempered glass doors and windows and stainless steel hinges with built-in safety switches. Their sanitary, raised track conveyor makes cleaning easy. No stopper, no cap pick up with a reject station available.

External Vial Washers

Benefits

Effective and safe cleaning: Specialized transport system with enclosure to prevent moisture ingress and potential bacterial contamination

Compact and flexible: Small footprint systems designed for vials from 2-125 mL; changeover for different vial formats takes just 15 minutes

Easy to use: Recipes use servodriven adjustments to guarantee repeatable positions of the vials in relation to the cleaning solution

EVW-100

High Output External Vial Washer

Vials filled with potent drugs such as antibiotics, cytotoxics and cytostatics need to be cleaned before further processing. The EVW-Series is the industries’ only external washer to completely encapsulate vial caps with a watertight seal.

By enclosing the aluminium cap between two opposed belts, the seal that is created prevents the cleaning agent from entering the cap area, thereby eliminating potential future bacterial contamination.

Advantages include:
• High washing efficiency
• Highly effective drying
• Protection of the seals
• Flexible transport system
• Short and reliable changeover time
• Longer processing time

Another advantage of sealing the cap is the application of pressurised water for cleaning the entire vial body, including the bottom.

Operation is menu-driven through the human machine interface (HMI). PLC-controlled servo motors automatically set the output rate, the vial height and the water/air flow per vial size. The changeover to a different cap or vial format is tool-less and can be accomplished within 15 minutes.

SP i-Dositecno’s equipment documentation and validation protocols are among the best in the industry. Every machine comes with ‘As Built’ 3D assembly drawings, each with a bill of materials.

Furthermore, each machine is provided with material and welding certificates with corresponding isometric drawings and complete operator and maintenance instructions, electrical drawing package, and PLC/HMI programs.

Operation is menu-driven through the human machine interface (HMI). PLC-controlled servo motors automatically set the output rate, the vial height and the water/air flow per vial size. The changeover to a different cap or vial format is tool-less and can be accomplished within 15 minutes.

Trayloaders

HSTL-200

The TL range of trayloaders is designed for medium to high output aseptic and non aseptic applications. These trayloaders are simple to operate with quick changeover between vial sizes for minimal downtime. The layout of the work area and machine frame is designed to ensure no interruption of vertical airflow and ease of cleaning.

PLC control ensures that stepper motor speed and actuator movement is specific to each vial type and size. Changeover is quick and tool-free, taking less than 2 minutes. The TL series will handle plastic and glass vials up to 500ml with speeds of up to 400 vials per minute.