CONTAINMENT TECHNOLOGY BY THE USE OF BARRIER ISOLATORS.

The Concept of Roll Compactor with Isolators was originally derived by the “Nuclear Industry” in order to keep the operators safe from radioactive Isotopes. Eventually this technology was adopted into the pharmaceutical industry to address operator safety from highly potent API’s. After years of evolution & upgrades the Barrier Isolators are looked upon as safer, easier & cheaper alternatives for handling High Potent API’s (Hormones, Cytotoxic, etc.).

Isolators provide a contained & controlled environment on a smaller scale compared to a clean room. The result is achieving ergonomic operation in an almost germ / contaminants free working atmosphere. All of this is achieved at a much smaller scale with minimized cost of cleaning, air cycles, validation & maintenance in comparison to a clean room.

At Chamunda Containment Solution’s we understand the need of the ever evolving API market to handle API drugs with maximum safety with comparative minimum cost of handling. We are deriving systems which are capable of handling wet, dry mass & Liquid from a range of OEL 3 to OEL 5. We are backed up by consultants from Europe who guides us in achieving the desired goal.

Chamunda has a complete setup for design & manufacturing of both Process equipment’s & Isolators in house. This provides us with absolute control over customization & equipment integration with Rigid Isolators*.

Our Product Range consists of the following.

•           Sampling & Dispensing Isolator.
•           Isolator for Granulation.
•           Isolator for Roll compactor & dry process line.
•           Isolator for Auto coater.
•           Close loop Granulation lines.
•           Colloid mill with containment.

Special Features

•           Integrated process equipment’s with Rigid –ve pressure Barrier Isolators
•           Options for material ingress i.e. Pass Box, RTP’s & SBV’s
•           Options for material discharge i.e. Out Pass Box, RTP’s, SBV’s, and Continuous Liners or BIBO Sleeves.
•           In Process Containers with SBV’s.
•           Pressure controlled cycles with Temperature, Humidity & O2 monitoring & control if required.
•           Integrated WIP systems with Skid.
•           Drum loading systems.
•           Safe Change filters.
•           Glove integrity testing.
•           Optimum ergonomics via ergo trials.
•      Complete automation using PLC + HMI (10”- Mitsubishi / optional Siemens make), compliant to 21 CFR if required.
•           Support for pressure test OEL test provided.
•           In compliance with cGMP norms.

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High Speed Double Rotary Tablet Press Machine

MACHINE APPLICATION

AMPLUS - III High Speed Double Rotary Tablet Press is aptly designed for use in pharmaceutical Industry for Large Batch size Production for Single Layer as well as Bi-Layer Tablets. It does find its applications in many other similar process industries.

MACHINE OPERATIONAL PRINCIPLE

The material (Blended Powder/ Granules) is to be filled to the die hole through the hopper and the Feeder. Then, the filling volume of the powder is adjusted by motorized Dozer & pressed under the Pre & Main Pressure Rolls. The tablets are formed under this process & discharged automatically through the discharge chute of the Tablet Press.

MACHINE DESCRIPTION

This is a Double Rotary Tablet Press with inbuilt 10 Ton Pre Compression & 10 Ton main Compression, with Key features of Interchangeable Turret facility among 51 STN D / 65 STN B/ 81 STN BB. This ergonomically designed machine is cGMP Compliant Tablet Press meeting all the parameters of Design (smooth corners & surfaces), Operator’s safety, Control systems, Metallurgy, Surface treatment and Easy accessibility for cleaning, assembling and dismantling of components etc.

AMPLUS - III series Rotary Tablet Presses are controlled by 15” IPC WITH COLOUR TOUCH SCREEN WITH 21 CFR PART 11 COMPLIANCE. IPC supports online helps to provide the Automation solutions through internet & hence minimize the Machine Down Time and production loss.

This series of machines are designed and made as per cGMP STANDARD & are capable to meet all international standards including USFDA & MHRA REQUIREMENTS.

A)    STRUCTURE

As the name suggests, the robust Structure design provides strength & stability to compression forces without vibration. Its sturdy construction based on 'TIE BEAM' design wherein the top frame, made of special C.I., supports the main body to withstand the pressure load during the entire tableting process. The trembling is also absorbed during the operation based on this structure. The structure is enclosed with SS 304 guards. The Tablet compression zone is covered with thick transparent acrylic guards. The machine is equipped with Anti Vibration mounts at the bottom.

B)    TURRET DRIVE

Centrally driven Turret is connected directly on the Main Drive Shaft of Heavy Duty Oil Immersed Gear Box to get the max torque at the Turret. It is designed to meet the standards of Low Noise Level below 80db. Large capacity motor ensures that there are no jerks or slippages while compressing even large tablets of size up to 25mm.

C)     TURRET

Highly accurately machined, 3 piece Turret with double tapper roller bearings, has SS 316 Die Table.

Upper & lower Punch Disk is made of Special Grade SGI Casting with Electroless Nickel Plating on the exposed portion in tableting zone. This Electroless Nickel plating provides excellent protection against corrosion from highly abrasive substances, salts, acids, alkali, humidity etc.

In upper Punch Disk, the keyway is given in upper punch bore for shaped punches. The Lower Disk is having the punch brake (Ball Plunger) which holds the lower punch, to reduce the weight variation & the Noise.

The lower wiper seal is fitted on the top part of the punch hole in order to block the Oil & dust from the Punch body.

Dies inserted in Die Holes are locked by specially designed & hardened Die Lock Assemblies.

The interchangeable Turret can be provided with option of ‘51D’, ‘65B’ or ‘81BB’ Tooling.

D)    PRE & MAIN COMPRESSION PRESSURE ROLLS ASSEMBLIES

Equal & High pressure of Pre & Main Compression rolls, improves the dwell time for better compression. It eliminates the problem of tablet capping and chipping even for difficult formulations or shaped tablets.

Pre & Main Compression Rolls are specially designed, to deliver uniform Pressure on both the Upper & Lower Punches.

The motorized Lower pressure Roll Assembly has Load Cell, fitted at Center the lower roll, which enables the compressing Force measurement & monitoring. (Numeric as well as Graphical)

E)     FILLING CAMS

3 types of the filling Cams are supplied along with the machine. A suitable one should be selected based on the Tablet Thickness. The maximum size of the Filling Cam is 20 mm.

 F)     FORCE FEEDER MECHANISM

Zero Clearance Force Feeder has User friendly design of the force feeder feeds the granules to the Die cavity uniformly. The Force Feeder has Single stage 3 Paddle design for optimum powder filling. Separate ACVFD Drive for Force Feeder is provided for uniform filling efficiency & weight control as well as to synchronize speed & feed both. Option of Clockwise & Anti Clockwise rotation of paddles can be selected from Touch Screen of IPC. It enables handling of difficult products with characteristics like low B.D., fluffiness, poor flow ability etc.

G)    FEATURES & ADVANTAGES OF AUTOMATION

•         All machine controls through IPC touch screen.

•         Auto sampling based on, either time or revolution or punch nos.

•         Initial startup & stop rejection by default

•         Auto rejection, of any single tablet, if out of prescribed compaction force limit based on CFC through AWC facility.

•         Graphical representation of pressure on individual punches at pre & main compression rolls.

•         4 level password securities to prevent unauthorized use.

•         Recipe management & recipe storage.

•         Audit trail reports with printing facility.

•         Post installation. PLC complaints can be handled by internet through team viewer

H)   AWC

•         The range of AWC is divided such as control, reject and data store.

•         Graphical representation of the value of both pre & main pressure.

•         Display of figurer and graph both for the value of pressure on each individual punch.

•         Indication / display, of any no. of the selected punch & the respective value of pressure applied on it.  

•         Filling depth can be adjusted, if the amount of filled powder is exceeded or shortened beyond preset value.

•         The faulty tablet will be rejected automatically through Single tablet rejection system.

•         All data like production, rejection samples taken. Batch time segments etc. are recorded.

•         Discharge chute with three compartments viz. Acceptable tablets, initial / auto reject & sampling tablets gate.

I)       CENTRALIZED SCADA MONITORING SYSTEM

Machine input & output status can be observed & monitored, in parallel to the machine connected panel, from outside, by any competent authorized person, while sitting in his office through any internet connected device.

BENEFITS OF SCADA:

•         Report generation in PDF.

•         Large no of recipe & data storage capability of IPC

•         Connectivity to any type of printer.

•         Graphical system representation.

•         Real time trending

•         Alarm history.

•         Audit trail.

•         Advanced security level.

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Tablet Compression Machines Market Size 2019-2026 | Product Capacity, Manufacturers, Share, Value, Consumption, Growth and Segmentation

The new research from Global QYResearch on TabletCompression Machines Market Report for 2019 expects to offer target gathering of people with the crisp point of view toward market and fill in the learning holes with the assistance of handled data and assessments from industry specialists. The data in the exploration report is all around handled and a report is aggregated by industry experts and prepared specialists in the field to guarantee of the nature of research.

The exploration is sponsored by broad and inside and out auxiliary research which includes reference to different measurable databases, national government archives, applicable patent and administrative databases, news articles, public statements, organization yearly reports, webcasts, budgetary reports, and various interior and outer restrictive databases. This evaluated information is cross-checked with industry specialists from different driving organizations in the market. After the whole confirmation process, these reports are imparted to topic specialists (SMEs) for adding further esteem and to pick up their keen feeling on the exploration. With such powerful procedure of information extraction, check, and finish, we solidly support the nature of our examination. With such broad and inside and out research and far reaching inclusion of data, it is dependably a plausibility of customers finding their ideal data in the report with walled in area of key segments and significant insights in all respects.

The worldwide Tablet Compression Machines advertise is esteemed at xx million US$ in 2018 is relied upon to achieve xx million US$ before the finish of 2025, developing at a CAGR of xx% amid 2019-2025.

This report centers around Tablet Compression Machines volume and incentive at worldwide dimension, territorial dimension and friends level. From a worldwide point of view, this report speaks to generally Tablet Compression Machines advertise measure by investigating authentic information and future prospect. Territorially, this report centers around a few key districts: North America, Europe, China and Japan.

At organization level, this report centers around the creation limit, ex-industrial facility value, income and piece of the pie for every maker canvassed in this report.

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