AWS Bio-Pharma Technologies, LLC

AWS Bio-Pharma Technologies, LLC

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AWS Bio-Pharma

Consulting Services

By Product:

	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
	Non-Aseptic Processing Liquid Processing Bottle Unscramblers Liquid Filling Cream & Ointment Fillers Form/Fill/Sealers Screw Cappers Powder Processing Mills & Sifters Mixers & Blenders Material Conveying Systems Tablet / Capsule Process Tablet Presses Tablet Coaters Auxiliary Equipment
	Packaging Equipment Aseptic & Non-Aseptic Packaging Equipment Labelers Banding Cotton & Dessicant Inserter Inspection Systems Automatic Split Capsule Sorter Cartoners
	Facility & Support Systems Tanks & Support Systems WFI & Piping Systems CIP & SIP Systems WIP & CIP Systems Modular Clean Rooms & Accessories Passivation of Stainless Steel Portable Clean Rooms/Dispensing Rooms

By Company:

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

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

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

PennTech Machinery Corporation (formerly Mengibar Applied Technologies) was founded in 1992. In the early 1990's the company offered a medium to high output rotary vial washer, the RW-1150 and a dual trayloader, model TL-200. Since that time, success in performance and reliability has led to an ever increasing and diverse product line. PennTech has increased its offering to include a RW-800, the industries only low to medium throughput (specific) continuous rotary vial washer, as well as a single tray trayloader, the TL-100. The company is slated to introduce a revolutionary filling machine (specifically for parenteral lines) within the 2006 timeframe.

PennTech has positioned itself as a major contender/supplier of equipment for the pharmaceutical, biotech and animal health industries. PennTech continues to develop new products and improve upon existing ones to accommodate the changing needs of our customers, while never losing sight of its commitment to excellence.

PennTech Machinery Corporation — Made in the USA

Contents

Key Benefits of a Rotary Washer
Controversy of Stationary Nozzles versus Penetrating Nozzles
Operational Highlights
Rotary Washer Documentation
Rotary Washer RW-1150
Rotary Washer RW-800
Tunnel & Tray Loaders TL-100 / TL-200
Accumulation Tables & Transfer Disks
Automatic Lyophilizer Loader / Unloader
Sanitary Conveyors

Key Benefits of a Rotary Washer

Cleanliness
There are no moving parts in the washing chamber (except for the central turret).
In-line vial washers with chain based drive mechanisms inherently create more particulates than rotary vial washers.
Functionality
Each vial size has a dedicated set of change parts. Each set of change parts is designed to handle a specific size vial. In other words, each vial is optimally exposed to internal and external water/air spraying.
In-line vial washers, to the contrary, use vial holders (buckets) made for all vial sizes, from the smallest to the largest. This is a compromise to the effectiveness of the washing function.
Visibility
Due to the transparent polycarbonate cover over the washing chamber, the total washing function can be visually inspected. This is practically impossible with in-line vial washers.
Compact Size
The rotary design allows for a small footprint. In fact, the PennTech machine occupies 2.7 meter² (1.9m x 1.4m) and is the most compact vial washing machine on the market today.
Single File Container Outfeed
The cleaned vials leave the washer in a single-file fashion. This means that the vials are immediately available for trayloading or for transporting to the filling machine in the clean room. In addition, when continuous sterilizing is required (using a sterilization tunnel), the vials can be pushed onto the tunnel conveyor in a full loading pattern. This is a significant advantage over in-line vial washers whereby the loading pattern is less than optimum. This may result in "cold spots" in the sterilization tunnel.

Controversy of Stationary Nozzles versus Penetrating Nozzles

PennTech has chosen stationary nozzles, as opposed to penetrating nozzles. There are several reasons for this choice:

Penetrating nozzles move in and out of the vials
Everything that moves generates particulates. This is in violation with the function of a vial washer; i.e., to remove particulates.
Tests have shown that stationary nozzles are as effective as penetrating nozzles
The reason for this is due to the high velocity of the waterjet exiting the spray pipe; the stationary nozzle maintains its convergent nature as if an invisible spray pipe is surrounding the waterjet. Even small, 2 ml vial with a 13 mm neck finish are effectively cleaned.
Penetrating nozzles may hit the neck finish of the vial and bend
Bent nozzles are not only ineffective; they may jeopardize the validation of the batch in addition to a higher rate of broken glass.

Operational Highlights

From the rotary infeed table, vials are automatically loaded into dedicated carriers unique to each ind. vial size.
During the washing treatment, the vials are indexed in an inverted position in such a way that the bottles line up exactly with the spray pipes across the neck openings.
Water and air spraying cycles start when the vials are lined up with the spray jets and stop during the indexing movement.
The washing cycles are selected by the customer. Selection is made using combinations of the following:
Recirculated WFI (water for injection)
Virgin WFI
Sterile Air
For the RW-1150, there are sixteen indexing positions, thirteen of which can be used for the washing treatment. On the RW-800, there are 8 positions, 6 of which can be used for different washing cycles.
The treatment time with WFI depends on the selected washing program and the selected output rate and may vary between ten and thirty seconds. In addition, sterile air blowing time may vary between 7 and 20 seconds.
The linear motion of the outfeed pusher as well as acceleration, deceleration and positioning is automatically selected (via PLC) for the vial size in use.
The operator controls the machine through an Allen Bradley PanelView 550 or optional PanelView 1000 operator interface with programmable input keys and error messages.
The changeover to a different vial size requires only the use of a 5mm Allen key and is accomplished in less than fifteen minutes by one operator
In whole, the machine consists of the following components:
- Infeed turntable with positive drive infeed mechanism
- Washing chamber with vial carriers
- Spray pipes
- Central indexing turret with drive mechanism
- Water/air distribution system
- Wash piping system
- Container outfeed mechanism
- Electrical panel with PLC
- Easy to use operator interface

Rotary Washer Documentation

PennTech creates precise manuals and documentation individualized to each and every machine including the following items:

Operating Instructions
Preventive Maintenance
Trouble Shooting
3D Assembly Drawings (AutoCAD)
Recommended Spare Parts List
Programming Ladder Diagrams
Electrical Schematics
Original Equipment Manufacturer's Manuals
Certificates of Compliance - Material
Certificates of Compliance - Component

Rotary Washer RW-1150

The RW series of washing machines are designed to clean glass and plastic vials at an output rate between 2,000 and 24,000 vials per hour. Vial size range: 1-500cc

Features:

The speed of the washer can be electronically adjusted between 10 and 30 indexes per minute.
Thirteen effective washing or air blowing positions
Separation between infeed and outfeed - position 16
Intermittent washing and air blowing (Reduces WFI consumption by approximately 25%.)
Three washing zones:

        Zone 1: Recirculated WFI using ext. tank with heating element, centrifugal pump and 10 inch(.2µ) filter

        Zone 2: Virgin WFI (water for injection)

        Zone 3: Sterile air
Water and air distribution thru independent external manifold system allows for easy washing program changes
All water and air contact parts are constructed of AISI-316 stainless steel
All water and air pipes are pitched 3 mm per 30 cm (1/8" per foot), in order to obtain total system drainage
Low air and water pressure protection with automatic system shutdown
Pneumatically raising and lowering polycarbonate cover over wash chamber
Standard Allen Bradley^® PanelView 550 or optional PanelView 1000
8 color touch screen operator interface
Allen Bradley SLC-5/04 or SLC-505 PLC

Stepper motor controlled outfeed actuator

Rotary Washer RW-800

The RW-800 is a medium sized version of the RW-1150 and runs upwards of 400 vials per minute.

Features:

Six effective washing or air-blowing positions
Two to three washing zones:
- Zone 1: Recirculated WFI (optional)
- Zone 2: Virgin WFI
- Zone 3: Sterile air

Water and air distribution through independent external manifolds allow for easy washing program changes
All water and air contact parts are constructed of 316L stainless steel
All water and air pipes are pitched 3 mm per 30 cm (1/8" per foot), in order to obtain total system drainage
Low air and water pressure protection with automatic system shut down
Allen Bradley PanelView 550 (or optional PanelView 1000) operator interface terminal mounted on gooseneck with emergency stop
Allen Bradley SLC 5/04 or SLC 5/05 PLC
Servomotor operated main drive
Stepper motor controlled outfeed actuator

Tunnel & Tray Loaders

TL-100 / TL-200

    The PennTech single tray loader (TL-100) is designed for low to medium output, aseptic and non-aseptic applications, while the dual tray loader (TL-200) is similar but designed for higher output. Both are 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) for the TL-100, and 400 vials per minute for the TL-200. 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 tool free changeover procedure of the TL-100/TL-200 is quick and easy. Changeover should never take more than two minutes. To change vial size, simply change the pusher bar and associated change parts. Then, select a setting on the control panel and the actuator(s) automatically go to their pre-programmed starting position for that vial size.

Features:

Functioning
        The TL-100 has one loading platform. Once the tray is full, the operator replaces it with an empty one and the machine will immediately resume loading the tray. 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 indicates that the tray can be replaced.

Ease of Operation
        Through the control panel, the operator can select the vial that will be processed. The PLC will now instruct the stepper motor(s) as how to position the actuator(s). The setting of the actuator(s) is specific to the selected vial size; it is always in the optimum position.
In addition, through the PLC the stepper motor(s) is instructed as how fast and how far the actuator(s) has to move. For small unstable plastic vials the actuator speed is less than for 100 ml glass vials. Under PLC control, the actuator stroke for each vial size is exactly what it should be, not more, not less. In other words, without operator involvement, the machine is automatically optimized for each vial.

Versatility
      The TL-100 can be ordered in the standard left to right execution or in the right to left execution (without additional cost). Different tray sizes can be handled by the machine through change parts as well as different tray materials. Glass and plastic vials can be processed from 1-500 ml. Vials are seamlessly loaded in a nested pattern.

Safety
       The machine is designed with safety in mind. Actuators are stepper motor controlled and come equipped with (programmable) encoders automatically halting production in the event of an obstruction.

Aseptic Operation
       There are no overhead parts that interfere with vertical unidirectional airflow. (see drawing) The machine frame is approximately 20 cm (8 inches) below the work surface to minimize the vertical airflow disturbance at the work surface. A special raised track conveyor (3 1/4" Rexnord 880) is used to aid the cleaning process.
        Also for cleaning purposes the tray bed and conveyor are mounted on columns, away from the machine frame. The machine is constructed from AISI-304 stainless steel, including frame, and AISI-316L where required.

The TL-100 comes with a complete set of documentation including:

Standard Operation Procedures (SOP)

Maintenance Procedures

Recommended spare parts

AutoCad drawings for all wear and tear parts and change parts (hard copy and compact disk)

Three dimensional assembly drawings

Detailed parts lists with OEM part numbers

PLC ladder diagrams

OEM documentation and manuals

Process and material certifications