Drugsformulations

General

Equipment No.

Description

Use

FIeld Identification

Operator Safety: Safe machine operation is of utmost importance. To ensure safety, all upper guards have been fitted with interlock switches. If a guard is open, while the machine is in operation, the machine will stop immediately. Lower guards are fitted with lockable handles.

Cleanliness and Cleavability: Within the tableting zone there are no painted surfaces and the large cabinet combined with wide counter balanced upper guards give excellent access to the area for cleaning purposes. Lower punch scraper seals prevent material passing through the lower punch guides into the cam tracks.. This results in reduced wear and extended tool life in addition to enabling the machine to run for longer periods between clean downs. Externally the machine is paint free and the stainless steel panels on all sides facilitate cleaning operations. A hinged transparent cover protects the control panel, although the safety stop is operated without opening the cover. Easy access to upper Punch for removal due to quick release mechanism. The upper punches are protected from dust by an upper punch guard. This helps in the minimizing of tight upper punches and reduced, punch and cam wear. Hoppers, doors and guards of lower cabinets etc. Are quick removable without using any tools. This also helps reducing downtime.

Obviating Dust Hazards: In high speed tableting, Dust extraction is essential. Dust extraction nozzles at compression point are provided as standard. Suitable dust extractor unit with necessary hose piping can be supplied extra, for fitting to machine when a centralized system is not available.

Quick and easy tool change over: Machine has been designed to minimize the change over time. The weight adjustment section is easily removable which provides goods access for the removal/replacement of lower punches and dies. This adjustment can be done without opening lower cabinet, away from compression zone. The hand wheel is conveniently located for indexing the turret suring tool changeover with single operator.

Feeding of Material: Machine is fitted with rotary feeders specially designed for high speed operation. Exceptional tablet weight consistency and operational cleanliness are ensured. Feeders can be easily removed for cleaning between product changeover. Effective feeder leveling ensures that the feeder base can be easily set and maintained at the desired height. Resetting of the feeder base is not required even if the feeder is removed for cleaning. The stainless steel hoppers have powder sights for visual checking. Material flow from hopper to feeder is easily regulated within fine limits, without having to shut down the machine. Powder spilling losses are kept to an absolute minimum by the powder circulating band fitted to the feeder. Generated cam tracks, which reduce machine and tool loadings, ensure highly efficient operation with low wear factors Three sets of fill cams keep the die table clean and prevent over loading of the rotary feeders. These cams cover the full filling range of the machine.

Drive Arrangement and Lubrication: The drive is transmitted from the electric motor with variable frequency control to gearbox through timing belt. The final drive is by replaceable internal helical gearing. The turret is mounted on bronze bushes and antifriction thrust bearings. The gear drive and turret bearings are continuously pumped and lubricated. All pressure pins are lubricated by an automatic intermittent forced feed system and lubrication is provided to the punch heads. All revolving parts are mounted an anti-friction bearings.

Pressure Loading and Overload Release:

The pressure units are self-contained to obviate stress on other parts of the machine. Pressure is applied by means of manual hydraulic pump. The overload release is unique in its operation on both upper and lower punches, providing a valuable extra safeguards against overload. Effectively it is the safety valve of the machine. It ensures that any overloading transmitted to the punches is only a small percentage of the total loading. Both upper and lower pressure rolls are adjustable, allowing variation of position at which the tablet is made in the die. This is particularly desirable with difficult materials, or when thinner tablets are being produced. Double die life can be obtained by reversing the dies.

Weight adjustment, tablet thickness and pressure roll positions are all graduated, enabling matched setting to be made both sides of the machine. Adjustments may be carried out while the machine is running. Removable panels allow access for a fork lift truck and give a clearance of approximately 100 mm below the machine. Alternatively the machine may be moved by a direct lift applied to an eyebolt on the top of machine.

Allocated floor space for the equipment is with a clear ceiling height of  2 Mts. Approx.

To be installed in  2.5 x2.5 Mts. Area.

(i)       Room Temperature NMT 27⁰ C

(ii)     RH  NMT 60%

(iii)   Flame proof area

Electrical Construction

Flameproof

Operational requirements

Capacity

Control Parameter

Control

Functional Requirements

Power failure / recovery

No. of Station -35

Max. operating pressure –6.5 Ton (65 kn)

Max. Tablet Diameter – 16 mm

Max. Depth of fill – 17.5 mm

Max. Thickness of tablet – 11.1 mm

Output Tab./Hr. –70,000 to 1,68,000

Upper Punch Penetration – 1.5mm to 8mm

Turret RPM (min. /max.) – 16 to 40 RPM

Electric Motor – 7.5 HP / 1440 RPM/ 3 Ph.

The system shall operate with a minimum of operator involvement. Operation shall be safe from an operator and environmental standpoint.

The system shall be operated locally at the equipment itself

Re-designed variable speed pulley.

ü Turret of SG IRON 500/7 grade.

ü Sturdy and easy fit M Type Feed Frame with sufficient height to avoid spill over of powder.

ü Central oil lubrication system with hand pump.

ü Machine can be equipped to compress two-layered tablets

ü Cam tracks and pressure rolls made out of alloy steel for maximum wear resistance and long life. Worm is made up Phosphor Bronze.

ü Machine is totally enclosed i.e. Top half of the machine (Compression zone) with S.S. hood, acrylic covers, and lower half of the machine complete with SS Cover in GMP Model and in standard model top hood and lower half of the machine with MS color painted. This reduces the noise level and to & fro flow of dust between compression zone and machine room.

ü Anti vibration mounting provided, hence no foundation required.

ü Large paints free compression zone with plenty of space for ease of cleaning & accessibility of components in GMP Model.

ü Ease of operation and maintenance.

ü Higher turret speed 15 to 42 RPM gives higher output than standard machine.

ü Friction plate is provided on cam plate to minimize wear & tear of cam track, which also facilitates its easy replacement.

ü Fly over on upper punch is provided to avoid the jumping of upper punches.

ü Reverse direction motion protection to provide to avoid major accident.

ü Imported needle roller bearing to provid at the bottom of turret, which is immersed in oil for frictionless rotation.

ü Aluminum covers for rotor teeth.

ü Auto Lubrication pump to provide on demand (Optional).

ü Force Feeder to provide on demand (Optional).

In the event of a power failure, the system shall protect product against damage. The system will stop in a safe mode automatically upon loss of electricity, air or other major utility and will require operator intervention of re-start

Depending upon the options chose in the overview section, the system will:

i. Manually restart based on operator inputs (operator initiates power recovery sequence).

Utilities

Maintenance

i.      Maintenance and operation manuals alongwith as built drawings

ii.    Lubrication instructions

iii.  Daily checks on machine

vi. Cleaning procedures

Commissioning and Documentation

Development

IQ/OQ/PQ to be completed by the supplier along with M/s Sano Cito Therapeutics Inc representatives.

The Supplier to demonstrate the Performance of the machine at site as per agreed terms.

The Supplier to submit the following certificates:

MOC Certificates.

Calibration certificates of all the instruments used having traceability to NPL / NIST

Performance certificates of Tests conducted

At manufacturers/Supplier end for Motors / Gear Box / Fan and other critical bought out items with Serial nos.

The Supplier shall provide a Project Manager for the project to provide a single communication point with the User.

Start up support

Post start up support

Telephone / Fax / E mail ID / Address

Replacement parts availability list (normal lead times shall be listed).

System improvements (supplier shall notify user of any improvements.