AWS Bio-Pharma Technologies, LLC    

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AWS Bio-Pharma

[New!]Consulting Services

Owner-Engineer Consulting

 

By Product:

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Aseptic Processing

  • Washing

    • Rotary Washers

    • In-Line Washers

    • Exterior Vial Washers

    • Equipment/Parts Washers

  • Sterilization & Depyrogenation

    • Sterilization & Depyrogenation Tunnels

    • Depyrogenation Ovens

    • Autoclaves

  • Filling

    • VFM Monoblock

    • Precision, Long-life Peristaltic System

  • Stopper Processing

    • Stopper Washers

    • Stopper Washer/Sterilizing

  • Capping

    • Aseptic Capping

    • Rotary Capper

  • Isolation Devices

    • R.A.B.S.

    • Isolators

    • Laminar Flow Units

  • Transfer & Other Devices

    • Accumulation Tables

    • Transfer Disks

    • Sanitary Conveyors

    • Tunnel Loaders

    • Tray (Un)Loaders

    • Syringe Loaders

    • Automatic Lyo Loader/Unloader

    • Trays

    • Racks & Carts
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Non-Aseptic Processing
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Packaging Equipment
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Facility & Support Systems

By Company:

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Aseptic Processing

  • Steriline

    • Washers

    • Depyrogenation

    • Fillers / Cappers

    • Isolation Devices

    • Exterior Washers

  • PennTech

    • Washers

    • Tray loaders

    • Conveyors

    • Lyophilizers

    • Lyo-loading systems

  • BEAM

    • MajiCap Capping

  • ICOS

    • Ovens

    • Autoclaves

    • Stopper/Washer Processing

    • Glassware Washers

  • Hurst

    • Label Removal Systems

    • Trays, Racks, & Carts

    • Tray Loaders & Unloaders

  • Dabrico

    • Semi-Automatic Parenteral Inspection

  • Colanar

    • Precision, Long-Life Peristaltic Filing Systems
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Non-Aseptic Processing & Packaging

  • NICOMAC

    • Modular Clean Rooms & Accessories

    • Tablet Presses

    • Tablet Coaters

    • Powder Processing

  • Hurst

    • Label Removal Systems

    • Trays, Racks, & Carts

    • Tray Loaders & Unloaders

  • Capmatic

    • Unscramblers

    • Fillers

    • Cappers

    • Labelers

    • Banders

    • Cotton & Desiccant Inserters

    • Cartoners
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Facility & Support Systems

  • A&B Process Systems

    • Formulation Tanks, Reactors, Other Vessels

    • WFI Distribution, Tanks

    • Hi-Purity process piping

  • Cal-Chem

    • Passivation of Stainless Steel

  • MicroWest

    • Computerized Maintenance Management Systems

 

AWS represents the highest quality, new biotech and pharmaceutical manufacturing equipment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
 

 

Steriline S.r.l. was founded in 1989 to produce automated manufacturing equipment for the pharmaceutical industry.  Originally, Steriline's focus was to produce the highest quality Depyrogenation Tunnels, at lower costs than the big companies.  Having succeeded at that, and having over 100 tunnel in the field, Steriline now designs and fabricates the finest quality parenteral manufacturing equipment at its factory in Albese Con Cassano, Italy (near Milan).   Steriline parenteral manufacturing equipment includes:

Compact Washer & Depyrogenation Tunnel[New!]

Tunnels

Washers

Other Steriline Equipment:

    Steriline provides extensive documentation from their superior Quality & Assurance Dept. Go HERE for more information

    Click one of the following links to view many of the General Theories, Specifications, and Advantages of Steriline washers and tunnels!

            Steriline Washer Advantages

            Steriline Tunnel Advantages

 

In addition to Steriline's vast array of parenteral processing equipment for vials, ampoules, and syringes, they are accustomed to working with customer's for any special equipment modifications. Please feel free to find out more about Steriline either online HERE or contact an AWS representative HERE!

  • All Steriline equipment is manufactured to comply with the demanding requirements of cGMP and GAMP standards.

Compact Washer & Depyrogenation Tunnel

    Steriline has developed a small footprint vial (or ampoule) rotary washing machine and depyrogenating tunnel suitable for clinical manufacturing, laboratory, and R&D applications. Based on a monoblock principal, the washing machine is fully integrated with a laminar flow depyrogenation tunnel on a single frame.

    The rotary washing machine, utilizes gripper mechanisms to handle the glassware and ensures thorough washing and the siliconization of the glassware. The glassware is loaded onto a rotating table and then automatically loaded into the grippers. The glassware passes through the washing and drying station in an upside down position. The washer is equipped with needles which are lifted to penetrate the glassware and then spray the appropriate washing fluid(s) and the compressed air.

    After washing, the glassware is turned up-right and directly discharged onto the depyrogenation tunnel conveyor belt. The vials pass through the inlet chamber then enter the hot chamber, where the depyrogenating process takes place. The glassware never stops moving and then enters the cooling chamber to cool down to a suitable temperature before discharge. The conveyor belt system is divided in three parts to  increase the  efficiency of  each chamber. This system ensures a savings of energy normally lost to the heat up and cool down of the conveyor belt as it passes from chamber to chamber.

    At the end of the batch, all vials/ampoules are discharged onto the dead plate between the tunnel and the filling machine by means of a discharge bar.  The depyrogenating tunnel has the added advantage of recycling the air in all the three chambers, which allows to remove many of the traditional intake and exhaust ducts. The pressure differential between the cooling chamber and the inlet chamber traditionally allows for about 100 air changes per hour in each chamber.

    The highly accurate automatic control of air speed in the chambers and of the pressure control inside the tunnel has always been one of the greatest advantages of Steriline's depyrogenating tunnels.

    When the depyrogenating tunnel is equipped with the optional dry heat sterilizable cooling chamber, a heated airtight door is provided. This option also enables the connection of the tunnel to the downstream isolator.

    A user-friendly touch screen HMI provides a seamless interface between the operator and the PLC.

    A remarkable break though in technology, in this small footprint, this washing and depyrogenation line is fully compliant with GAMP, cGMP regulations and the latest FDA requirements. The same monoblock concept can also be applied on our full size production equipment.

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Compact Washing & Depyrogenation Monoblock

Rotary Washer with Depyrogenation Tunnel, combined onto approximately a 3' x 7.5' single frame

 

ST Series Laminar Flow Sterilizing & Depyrogentation Tunnel

 

ST Series laminar flow tunnels have been designed to fully sterilize and depyrogenate glass containers using a continuous process while maintaining a Class 100 (Grade A) environment for the length of the tunnel.  Steriline laminar flow tunnels consist of three chambers:

- the inlet chamber dries and preheats vials and prevents hot air back flow from the hot chamber the hot chamber subjects vials to the thermal cycle for sterilization and depyrogenation;
- the cooling chamber cools vials to the suitable temperature to be discharged into the sterile filling room.
 
This design allows higher production speeds, more compact dimensions, energy savings and better control of the critical process parameters (air & belt speed and pressure differentials).

The various ST models (Sterilizing Tunnels) have identical design concepts but with different output capacities.  More than 20 models that have a wide range of options including automatic air balance, air speed monitoring and automatic adjustment, a conveyor belt cleaning system, door position monitoring and automatic adjustments, ports for  for particle monitoring, and automatic discharge of final vials are all available to meet any specific customer requirements.

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Sterilization and Depyrogenation Tunnel (ST Series)

DT Series Drying Tunnels

 
    These drying tunnels are designed to dry vials with low heat after initial washing or final exterior washing (by External Decontaminating Machines).  After the drying cycle the vials are perfectly dried, cool and suitable for the next processing step.
Applications where the DT Series Drying Tunnels are most beneficial include:
  • Dry powder filling after initial washing
  • ØLabeling after Final exterior vial washing
  • ØPre Ink Jet applications
    The tunnels are composed of three chambers, the first as a buffer, the second to dry the glassware and the third too cool down the glassware to room temperature.
 
    The Drying Tunnel consists of three chambers, the first as a buffer, the second to dry the glassware and the third too cool down the glassware to room temperature.

    The operator selects the proper vial to be processed and the PLC adjusts automatically all the parameters (temperatures, fan speeds and belt speed) based on the specific vial’s pre-programmed recipe.  The cycle is fully controlled by the fans, electric heaters, cooling coils and HEPA filters (if required). 

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VW Series Washing Machines

(for larger vials and bottles)

 

    These washers are designed to process vials with an output up to 24,000vph (400vpm). The vials are handled gently and with low speed motion.  DelrinTM  materials help avoid shocks.  HostaformTM Acetylic Resin baskets hold the vials during processing and keep them centered.

    Stainless steel cones center the needles into the vials. Nylon chutes and channels guide the vials at the discharge.  The washing cycles can include ultrasound, fresh water, recycled water, compressed air, silicone, hot air drying, or others as required.

    Any style or size of vial can be processed, each with its own cycle (up to ten washing cycles are available).   All of the following process parameters are controlled via the PLC: temperature, pressure, spraying time of each media and cycle speed.  All the process parameters are adjustable (password protected) and all cycles (washing and drying) are automatic.   The screen displays all alarms automatically.

Materials of Construction

    The parts in contact with process fluids are 316L stainless steel;  304 is utilized for parts that are not in contact with interior of the vials or the process fluids.  The finishes range from mill finish to mirror polished.  All welding points are mechanically polished and passivated.  The valves are sanitary diaphragm type and pneumatically actuated; the fittings are sanitary style and all piping is fully drainable.  As with all Steriline equipment, these washing machines are manufactured in accordance to cGMP standards.

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AW Series Washing Machines

(for ampoules and small vials)

 

    These washers are designed to process ampules and small vials with an output up to 40,000vph (665vpm). The vials are handled gently, with low speed motion. DelrinTM materials help avoid shocks. HostaformTM Acetylic Resin baskets hold the vials during processing and keep them centered. Stainless steel cones center the needles into the vials. Nylon chutes and channels guide the vials at the discharge.  Possible washing cycles include ultrasound, fresh water, recycled water, compressed air, silicone, hot air drying, or others as required.

    The control board is equipped with a PLC, keyboard and display.   Any style and size of vial can be processed, each with its own cycle (up to ten washing cycles are available).   All of the following process parameters are controlled: temperature, pressure, spraying time of each media and cycle speed.  All the process parameters are adjustable (password protected); and all cycles (washing and drying) are automatic.   The screen displays all alarms automatically.
Materials of Construction
    The parts in contact with process fluids are 316L stainless steel;  304 is utilized for parts that are not in contact with interior of the vials and the process fluids (i.e. frame, shafts, bearings, etc.).  The finishes range from mill finish to mirror polished.  All welding points are mechanically polished and passivated.  The valves are sanitary diaphragm type and pneumatically actuated; the fittings are sanitary style and all the piping is fully drainable.  As with all Steriline equipment, these washing machines are manufactured in accordance to cGMP standards

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SW Series Compact Low Speed Vial/Ampoule Washers

 

    These smaller foot print washers are designed to process ampules and vials with lower output than the VW Series. The vials are handled gently, with low speed motion. DelrinTM materials help avoid shocks.   HostaformTM Acetylic Resin baskets hold the vials during processing and keep them centered. Stainless steel cones center the needles into the vials. Nylon chutes and channels guide the vials at the discharge.  Possible washing cycles include ultrasound, fresh water, recycled water, compressed air, silicone, hot air drying, or others as required. 

    The control board is equipped with a PLC, keyboard and display.   Any ampoule or small vial can be processed, each with its own cycle (up to ten washing cycles are available).   All of the following process parameters are controlled: temperature, pressure,spraying time of each media and cycle speed.  All the process parameters are adjustable (password protected); all cycles (washing and drying) are automatic. The screen displays all alarms automatically.

 
    All parts in contact with process fluids are 316L stainless steel;  304 is utilized for parts that are not in contact with interior of the vials and the process fluids (i.e. frame, shafts, bearings, etc.).  The finishes range from mill finish to mirror polished.  All welding points are mechanically polished and passivated.  The valves are sanitary diaphragm type and pneumatically actuated; the fittings are sanitary style and all the piping is fully drainable.  As with all Steriline equipment, these washing machines are manufactured in accordance to cGMP standards

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RA Series Rotary Washers

   

The RA Series rotary style washer with intermittent motion is designed to process vials, ampoules, and syringes with an output of up to 2,400 pph (40ppm).  The glassware is loaded into holders which rotate the vials upside down for easy access cleaning.  Needles are use to penetrate the neck of the vial and spray the appropriate washing fluids and compressed air, to ensure a complete cleaning cycle.  Available process cycle choices include recycled water, new water, compressed air, silicone, or others (per your URS).  Glassware can be discharged after the cleaning process to either a traying station, or to a tunnel in-feed conveyor belt.

The control board is equipped with a PLC and touch screen HMI display.   Any ampoule or small vial can be processed, each with its own cycle and programmed process vials.   All of the process parameters are controlled including: temperature, pressure, fluid spraying time and cycle speed.  All the process parameters are adjustable (password protected); all cycles (washing and drying) are automatic. The screen displays all alarms automatically.

 
    All parts in contact with process fluids are 316L stainless steel;  304 is utilized for parts that are not in contact with interior of the vials and the process fluids (i.e. frame, shafts, bearings, etc.).  The finishes range from mill finish to mirror polished.  All welding points are argon atmosphere treated and then mechanically polished and passivated.  The valves are high purity diaphragm type and pneumatically actuated; the fittings are tri-clamp style and all piping is fully drainable.  As with all Steriline equipment, these washing machines are manufactured in accordance to cGMP standards.
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RC Series Rotary Washers

 

    The RC Series rotary style washer with continuous motion is designed to process vials, ampoules, and syringes with an output of up to 18,000 pph (300ppm).  The glassware is loaded into holders which rotate the vials upside down for easy access cleaning.  Needles are use to penetrate the neck of the vial and spray the appropriate washing fluids and compressed air, to ensure a complete cleaning cycle.  Available process cycle choices include recycled water, new water, compressed air, silicone, or others (per your URS).  Glassware can be discharged after the cleaning process to either a traying station, or to a tunnel in-feed conveyor belt.

The control board is equipped with a PLC and touch screen HMI display.   Any ampoule or small vial can be processed, each with its own cycle and programmed process vials.   All of the process parameters are controlled including: temperature, pressure, fluid spraying time and cycle speed.  All the process parameters are adjustable (password protected); all cycles (washing and drying) are automatic. The screen displays all alarms automatically.

 
    All parts in contact with process fluids are 316L stainless steel;  304 is utilized for parts that are not in contact with interior of the vials and the process fluids (i.e. frame, shafts, bearings, etc.).  The finishes range from mill finish to mirror polished.  All welding points are argon atmosphere treated and then mechanically polished and passivated.  The valves are high purity diaphragm type and pneumatically actuated; the fittings are tri-clamp style and all piping is fully drainable.  As with all Steriline equipment, these washing machines are manufactured in accordance to cGMP standards.
Washer Model Number of Stations Holders Per Pincher Max. Output (pph)
RC-1 10 1 3,000
RC-2 2 6,000
RC-3 3 9,000
RC-4 4 12,000
RC-5 5 15,000
RC-6 6 18,000

External Decontaminating Machines (EDM)
(Exterior Vial/Ampoule Washers)

 
    These machines are designed to decontaminate the external surfaces of ampules or vials.
 
Benefits of the EDM by Steriline:
ü    Seal protection,
ü    Process Repeatability,
ü    Minimized changeover time,
ü    Up to 350 vpm for smaller vials
ü    Machine foot print.
 
    The star-wheel is shaped to prevent water going into the seal.   Size changeover only consists of changing the star-wheel and takes less than five minutes.  Pockets in the star-wheel hold the vials while the processing fluids are sprayed on the exterior of the vials.  The nozzles are located in positions to best clean the vials. 
 
Working Description: 
    The EDM has an in-feed conveyor belt that is loaded from trays or by the conveyor of the preceding machine.  The in-feed belt supplies vials to the pockets in the star-wheel (suitable for the diameter of vials).  The star-wheel then transports the vials through the processing station to the discharge.  The shape of the pockets in the star-wheel creates a cavity between the vials and the pockets.  The process fluids are sprayed into this cavity and flow around the vials. During the transport by the star-wheel, the vials rotate and all external surfaces are washed.   The star-wheel is connected to a distributor plate for different process fluids distribution.  Each size container is processed with its own cycle and all process parameters are controlled by the PLC: temperature, pressure, and speed.
Model Speed (ppm) Power Usage (kW) Washing Usage (l/h) Compressed Air Usage(Nm3/h)
EDM1 300 2 - 10 200 - 300 10 - 30
EDM2 600 4 - 15 400 - 600 30 - 60

Download PDF Exterior Vial Washer Brochure

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Restricted Access Barrier System

(R.A.B.S.)

    The latest development in containment for Cytotoxic products.  Restricted Access Barrier System (RABS) provide the operator the space protections of an isolator when processing non-aseptic products, but is more cost effective than an isolator.  Operators pose the greatest risk of product contamination during “conventional cleanroom” aseptic processing.  Many different barriers of varying capabilities have been used to separate the operators from critical sites during aseptic processing with the objective of reducing the probability of contaminated product.  These solutions range from simple flexible curtains used on many traditional aseptic processing lines to advanced aseptic processing in isolators.  A RABS is an advanced aseptic processing system that can be utilized in a fill-finish area.  RABS provides an enclosed environment to reduce the risk of contamination to product, containers, closures, and product contact surfaces compared to the risks associated with conventional cleanroom operations.  RABS can operate as “doors closed” for processing with very low risk of contamination similar to isolators, or permit rare “open door interventions” provided appropriate measures are taken.  Steriline’s custom designs of RABS provides a level of separation between operator and product that affords product protection superior to traditional systems.

Download PDF c.R.A.B.S. Brochure

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Rotating Accumulation Tables

 
    As with all Steriline equipment, these Rotating Tables are manufactured in accordance to cGMP standards with choices of stainless steel to suite the customers needs.  Each Rotary Table can be integrated with any piece of Steriline equipment or can be purchased separately from our standard machines.

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Steriline Rotating Accumulation Table

Laminar Air Flow Units

 
    As with all Steriline equipment, these Laminar Air Flow Units are manufactured in accordance to cGMP standards with choices of materials to suite each customers needs. Steriline manufactures all sizes of Laminar Flow Units which can easily be adapted to any machine or area, ensuring control of the space and preventing contamination.

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Isolator Technology

    Steriline has developed isolators which are:
  • Shaped to avoid corners
  • Easily cleanable (either by hand or with CIP)
  • Tightly constructed for VHP sterilization
  • Unidirectional flow of air
    As with all Steriline equipment, these Laminar Air Flow Units are manufactured in accordance to cGMP standards with a range of materials to suite each customers needs.  Each isolator is equipped with 2 ports for integrity testing of the HEPA filters.  Fans are equipped in order to supply air to the HEPA filters.  Exhaust fans are used to control internal pressure.  The return air is contained in a double wall located in the opposite side of the area to be protected.  The air flows from the HEPA filters at the top of the isolator over the processing area, in a uniform direction.

Download PDF - Isolator Brochure

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Monoblock – Washer/Tunnel

    Steriline has developed a machine to easily handle instable glassware such as syringes, disporportionate vials, and ampoules.  This machine joins a washer and depyrogenation tunnel into a single frame.  The reduced footprint and the inline service facilitates the flow of vials and reduces the risks of glass breakage.

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Last modified: 12/20/09