Unused ACG 125 Litre Smart Coating System, Model SC-125

1 Unused ACG 125 Litre Smart Coating System, Model SC-125. Machine was manufactured in 2024 and has never been used. Currently sits in the OEM original crates.  For Aqueous (non-explosion proof) coating. 

Highlights:

·         All 316 Stainless Steel contact parts

·         Steam heated with freeze protection system

·         5 micron atomized spray

·         Allen Bradley PLC

·         Equipped with Camfil Active Deduster with HEPA Filter and NRV Isolation

·         Watson Marlow single drive, single head, non-XP Peristaltic Pump

·         50 L Stainless Steel non jacketed tank with pneumatic stirrer

·         Wall mounted HMI

·         CSA and Ulc Compliant and Certified

·         IQ/OQ and DQ documentation

From the OEM:

The machine base frame is made from painted carbon steel square tubing. The heavy duty

construction provides the structural base for the unique cantilever coating drum drive installation and the fully welded all stainless-steel processing chamber.

PROCESS CHAMBER: The Smart Coater machine uses a self supporting, fully welded processing chamber made of 316 stainless steel which houses the coating drum and spray arm assembly. Combined with the cantilever bearing of the coating drum and its sanitary process chamber design the machine stands for best cleaning results and advanced GMP compliance. The single piece chamber separates the processing area from the mechanical sections of the coater and incorporates an advanced sanitary chamber design with sloped surfaces and central drain located at the lowest section of the chamber, including:

·         One (1) pneumatically actuated drain valve.

·         One (1) Tri-Clover central machine drain port to connect to customer's drain line.

·         Integration into the process control system

·         Indicate status of the drain valve

·         Integrated functionality into the WIP recipe

·         One (1) differential pressure sensor to monitor and control the process chamber pressure during process, sampling and WIP

·         One (1) pneumatically operated over pressure relief valve to control chamber pressure during WIP

·         One (1) pneumatically operated vacuum relief valve to control chamber pressure during WIP

·         One (1) overflow drain including check valve and connection to central machine drain

·         Process chamber inner surfaces are ground to a maximum surface roughness of Ra <1.2 μm

·         One (1) explosion proofed design lamp to illuminate the process chamber, installed on top of the process chamber

·         One (1) ergonomically optimized front opening

·         Two (2) full wing style side doors with gas lifters and limit switches for cleaning, inspection and service access to the processing chamber and coating drum, complete with door seals made from FDA approved materials

·         Four (4) cleaning nozzles installed in the top section of the process chamber for WIP,

              allowing easy cleaning of the process chamber and the coating drum outside

·         Two (2) connection flanges for the inlet and outlet air ducting. Specially designed inlet air connecting flange allowing for a controlled and even distribution of inlet process air over the full width of the coating drum without the use of an inlet air shoe

·         Two (2) pneumatically actuated gas tight chamber flaps (inlet and outlet air), including limit switches (CLOSED), complete with flange and mating flange to be mounted to the connection flanges for inlet and outlet air of the process chamber. These flaps also define the WIP limits.

COATING DRUM: The fully perforated, horizontally installed coating drum is made of 316 stainless steel. All inner surfaces are mirror polished to a maximum surface roughness of Ra <0.5 μm. It features the following:

·         Conically shaped front and end piece with cylindrical middle section

·         One (1) drum drive assembly with a direct connected gear box motor in non explosion proof design with frequency converter, installed in the mechanical rear section of the system

·         One (1) lip seal arrangement mounted on to the coating drum drive, sealing the drum drive against the process chamber

·         One (1) set of process optimized mixing baffles made of 316 stainless steel and

             mirror polished to a maximum surface roughness of Ra <0.5 μm to guarantee a     

             homogenous distribution of tablets inside the tablet bed. The special baffles in   

             combination with the adjustability of the distance between the XꞏONETM coater

             nozzle and the tablet bed providing best possible coating results and process times

            while processing batch sizes from 30 to 100% of the working volume.

QUICK DISCHARGE: The quick discharge system is used to gently unload the product from the coating drum without operator intervention. The three (3) piece design is constructed of 316 stainless steel with product contact surfaces mirror polished to a maximum surface roughness of Ra <0.5 μm and includes:

·         One (1) specially designed discharge scoop including quick connector for easy installation in the coating drum. The scoop collects and transports the product to a central discharge chute while the coating drum is rotating. The discharge is supported by a specially designed discharge guides installed in the coating drum.

·         One (1) central discharge chute with Tri-Clover connection to the discharge scoop

·         One (1) discharge funnel attached to process chamber to guide the product gently into a customer’s container

OUTLET AIR SYSTEM: The outlet air system describes the section of the system layout starting from the outlet air flange of the coater up to the system outlet of processing air. Consisting of:

·         Outlet air shoe with seals made from FDA approved material. The outlet air shoe guides the process air thru the tablet bed in a defined pattern. The unique airflow separates the tablet bed into two sections:

·         1) The upper part of the tablet bed is defined as the spraying zone. This zone shall be as little as possible affected by the follow of processing air to avoid the spray drying of coating solution and as such reducing the process yield

·         2) The lower section of the tablet bed is used for drying of the coated tablets. The outlet air shoe is guiding the process air thru this part of the tablet bed resulting in an optimized drying of the freshly coated tablets and therefore reducing the required processing times

·         Process outlet air temperature measurement including temperature measuring port

              integrated into the outlet air connection of the coater complete with temperature     

             sensor,  "Plug in" design with Tri-Cover connection

·         Indication of measured values on HMI with alarm limits set points and alarm display.

SPRAYING: The Smart Coater is equipped with a sophisticated spraying system consisting of One (1) C-shaped spray arm made of 316 stainless steel sliding in and out of the coating drum using a roller-based rail system installed on top of the process chamber. For easy operator access to the coating drum, the spray arm can be locked in a service position, and includes:

·         One (1) mechanical end stop and "spray arm in place" sensor

·         One (1) front door made of 316 stainless steel installed on the spray arm with static seal

·         One (1) central media supply connection hub for spray liquid, cleaning media,

             atomization, pattern and control air

·         Spray ball(s) for cleaning of the coating drum and nozzle fixture. Connection to customer's cleaning media supply through the central media supply connection hub from outside of the coating drum

·         One (1) adjustable spray nozzle fixture to hold the coater nozzles made of 316 stainless steel and FDA approved materials. The fixture can be adjusted according to the process requirements. The following adjustability are provided,

·         Distance between the individual coater nozzles with indication

·         Angle of the coater nozzles against the product / tablet bed with mechanical locks

·         Distance between the product / tablet bed and the XꞏONETM coater nozzles

·         Coater nozzles made of 316 stainless steel and seals made from FDA approved materials The coater nozzle, produced by SCHLICK comes with the revolutionary split-design of dock and nozzle. By opening the central lock, the nozzle can be removed. The dock with all its connections stays on the spray nozzle fixture. This reduces the time required for realigning and readjustments. The coating nozzle features:

·         One (1) single form seal replacing the multiple O-rings of traditional nozzles

·         One (1) spray nozzle liquid insert, exchangeable design

·         Tool free assembly and disassembly

·         Maximum spray rates and an optimal homogenous spray pattern including SCHLICK's ABC (Anti-Bearding) Technology

·         One (1) nozzle needle with control air allowing for cleaning of the nozzle during the

             process as well as for shutting off the liquid supply at the end of the coating process   

            controlled from the HMI

·         Control of atomization air from the HMI including set points for air pressure on HMI, display of air pressure, display of alarms and atomization air filtration

·         Control of spray pattern air from the HMI including set points for air pressure on HMI, display of air pressure, display of alarms

D-SHAPED COATING DRUM ACCESS DOOR: The front door comes with one (1) hinged D-shaped coating drum access door made from safety glass. It allows for sampling, adjustments and monitoring of the process. Complete with:

·         Sampling function: The service function reduces the vacuum in the processing chamber for easy opening of the access door

·         One (1) sampling scoop

SOLUTION DELIVERY SKID: Single Head Single Drive Non-Flame Proof – FLOWTECH make closed coupled peristaltic pump for the supply of spray liquid to the coater nozzles including:

·         Pump head design: single head with spring-loaded liquid tube rollers

·         Drive set up: Single gearbox drive with variable speed control

·         Remote control allowing the speed of the pump to be adjusted on the HMI

·         Display of alarms on HMI

·         One (1) coating solution distribution manifold made of 316 stainless steel and FDA approved materials. The novel design equally distributes the coating solution to all coater nozzles and reduces the settlement of particles from the coating solution in the manifold.

·         One (1) set of tubes for: Spray liquid (including suction line), atomizing air and control air

·         One (1) pump trolley with antistatic wheels

5 MICRON. The supplied atomization air line for the spray system will be upgraded with the following components:

·         One (1) cartridge filter housing made from FDA approved materials

·         One (1) cartridge filter element pore size 5 micron

·         Installed in the machine tower junction box

SOFTWARE AND CONTROLS: ACG XꞏONE COMMAND in Non-Ex-proof Configuration.

The ACG XꞏONE COMMAND process control system is the next generation state of the art

control system fully compliant with FDA GAMP5 and CFR21 Part.11 requirements.

Industrial PC based control system with ALLEN BRADLEY or SIEMENS Programmable Logic

Controller (PLC). PEPPERL+FUCHS VisuNet visualization with a 19" touch screen as standard, designed and optimized for the use in the pharmaceutical industry. Suitable for the use in zone 2/22 environments. The HMI VisuNet EDGE enclosure was specifically designed for manufacturing environments where dust, water and other undesirable materials might accumulate. The enclosure construction with angled surfaces provides wash down capabilities with proper drainage to guarantee GMP compliant cleaning. The zenon software solution by COPADATA guarantees the compliance with international regulations. It offers Out-Of-The-Box GMP compliant automation through configurable prevalidated software modules for functions such as:

·         Recipe management and storage including recipe version / revision control

·         Audit-trails

·         Alarm management

·         Archiving of historical data and review

·         User Administration including password aging, auto lockout, minimum length and multi password control

·         System security

·         Reporting (selectable reporting function e.g. batch reports, recipes, alarms and trends)

·         Historian SQL server

·         Unlimited number of archives and unlimited number of freely selectable variables per archive

·         Parallel working archives

·         Different archive types in parallel

·         Time stamping in milliseconds

·         Full redundancy

·         High performance from proprietary binary data format

·         Integrated with zenon data analyzer

·         zenon data analyzer for central data storage including:

·         Analyzing of historical data and alarm reports

·         Real-time and historical data

·         Over seventy (70) pre-configured report templates

·         Automated distribution and storage of reports (Network connection required)

Using configurable batch control software modules significantly reduces the validation effort associated with automation in GMP environments by applying the ISPE GAMP5 guidelines for configurable software products (Category 4). Build in intelligent redundancies aim for systems to have highest reliability and availability, which guarantees consistent and robust performance for all XꞏONE products. The ACG XꞏONE COMMAND process control system allows:

·         Manual, automatic and maintenance operation modes

·         Equipment set up (spray test, filter cleaning, etc.)

·         Freely configurable production recipes using unlimited numbers of production steps and linked basic operation modules. Each basic operation can be individually configured according to the required process parameters

·         Storage for 500+ recipes for production processes

·         Monitoring of process parameters in real-time and as trend curves

·         Recall and evaluation of historical process parameters and batch reports

·         Display of the machine status and alarms including corresponding P&ID mapping for easy and quick trouble shooting

·         All process data and records are stored to one SQL database. This database serves as the original source of data for all requests whether they are viewed on the HMI, in printed report form, shared with a customer network system (ERP / MES / HISTORIAN) or copied electronically

·         Full database backup. A Raid 1 hard disk configuration is used to record all critical data on two (2) independent hard disks

·         Language of operation panel: English

·         Integrated operator guidance

·         Printing of batch reports (Format A4)

The primary electrical components are installed in a separate control panel to be located in the technical area (non explosion proofed zone) of the facility. It is made from painted carbon steel with cable feed from the bottom of the panel. Electric and pneumatic components are installed in separated sections. The control panel houses:

·         Industrial PC

·         PLC basic configuration rack along with interfaces

·         Uninterruptible power supply

·         Transformers for control voltage 230 VAC and 24 V DC

·         Complete electrical circuit board with breakers

·         VFD (Variable Frequency Drives)

·         Compressed control air distribution manifold with accessories

·         Other electrical and pneumatic components

DEHUMIDIFICATION SYSTEM: Dehumidification, single stage, increased performance (10°C dewpoint). The dehumidification system is designed for an ambient air condition of 35°C and 56% RH with an off coil temperature of 10°C and a maximum process air humidity level of 8 g/kg. Requires cold water supply temperature +6°C / return temperature +12°C. Consisting of:

·         Dehumidification coil for locally supplied cooling medium (chilled water or brine) made from copper tubing with aluminum fins

·         Droplet separator made from polypropylene

·         Condensate pan made of 304 stainless steel, including drain and siphon

·         Control valve (3/2-way valve) with temperature sensor. Self-regulating without ancillary energy.

 FINAL HEATER:   Heater section & steam coil designed for use with 12 PSIG steam

CAMFILL OUTLET AIR SYSTEM: Continuous heavy duty cartridge filter based deduster for indoor installation. Energy efficient downward airflow pattern delivers increased filtration efficiency. The system consists of:

·         Filter housing in vented design with clean air manifold

·         Reinforced for high vacuum pressure applications

·         Painted carbon steel construction (epoxy paint for inside and outside)

·         Round inlet and outlet flange complete with mating flanges

·         Automatic interval pulse cleaned system (compressed air). Including necessary manifold and valves

·         Removable dust collection bin

·         The exhaust air filter unit is provided with a grounding connection

·         High temperature modifications for seals and filters

·         Filter unit with filter cartridges

·         Integrated HEPA safety monitoring system that is conveniently installed, from the factory, on top of the standard Gold Series dust collector

·         Rotary airlock with zero speed switch and explosion proofed electric motor

PUMP: Watson Marlow Single Drive Multi Head Non-XP closed coupled peristaltic pump for the supply of spray liquid to coater nozzles including:

·         Pump head design: multiple heads with spring-loaded liquid tube rollers

·         Drive set up: Single gearbox drive in flame proof design with variable speed control

·         Remote control allowing the speed of the pump to be adjusted on the HMI

·         Display of alarms on HMI

·         One (1) set of tubes for spray liquid (including suction line), atomizing air and control air

·         One (1) pump trolley with antistatic wheels

SOLUTION MIXING VESSEL: 

·         One (1) mixing vessel made from 316 stainless steel inside surface roughness 0.5 Ra. Suitable to operated under vacuum 20 mbar abs

·         Non-insulated jacket for mixing vessel side walls

·         Mixing vessel in mobile execution with two (2) fixed and two (2) swiveling caster all with breaks. Caster wheels PU

·         One (1) top driven agitator with pneumatic drive made from 316 stainless steel.