Installation Qualification Protocol for Automatic Capsule Filling Machine

The purpose of the Installation Qualification Protocol for Automatic Capsule Filling Machine is to establish documentary evidence to ensure that the Automatic capsule filling machine system received matches the Design specification and also to ensure that it is properly and safely installed.

The signing of this approval page of the IQ Protocol for Automatic Capsule Filling Machine indicates agreement with the qualification approach described in this document. If a modification to the qualification approach becomes necessary, an addendum shall be prepared and approved. The protocol cannot be used for execution unless approved by the following authorities.

This Installation Qualification protocol for the Automatic capsule filling machine has been reviewed and approved by the following persons:

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PROCESS EQUIPMENT DESCRIPTION

The basic (Equipments) consists of the following subassemblies:

1. Structure Assembly:

This houses the main drive motor, powder drive motor, pneumatic and vacuum piping, all drive elements, and electrical control cabinet. The structure is enclosed on all four sides by removable covers. Removing the hand-wheel side cover exposes the filter regulator lubricator unit of the compressed air system, the pressure switch, and the main drive motor clutch. Removing the cover below the exit chute exposes the cam switch box and drive mechanism. When the cover located below the empty capsule loading area is removed, an electrical control panel is exposed.

2. Drive assembly:

This consists of the main motor, drive shaft, gears, cams, cam followers, bearings, housings, and brackets. Rotary indexing motion is given to the turret, dosing disc, and a reciprocating motion is given to various sections that move vertically by specially designed cams.

3. Turret Assembly:

The turret is a cylindrical disc. It has 8 pairs of cap and body bush holder plates with the cap plate located above the body plate. Each pair is radially equidistant around the turret center. The turret also houses a pneumatic cylinder and cams for providing motion to the cap and body bush holder plates.

4. Empty Capsule Holder Assembly:

This consists of a capsule hopper, capsule reservoir, magazine, rectifier block, horizontal finger assembly, and vacuum block. The reservoir has a baffle plate to regulate the flow of capsules in the reservoir. The magazine is mounted on a shaft. The vertical finger assembly and the capsule-releasing fingers are fitted on the magazine. A handle is provided to start or stop the release of capsules to the rectifier block. The released capsules are pushed by the horizontal finger assembly. A vacuum block located below the body bush holder plate moves up and down.

5. Powder Filling Device:

This consists of a hopper, stirrer, feed tube, powder level sensing device, and powder tub. The powder hopper is a stainless steel container fitted with an acrylic window. A powder stirrer is mounted centrally in the hopper and driven by a separate motor. At the delivery end of the hopper, an adjustable gate is provided to control the rate of powder flow and to facilitate the removal of powder at the end of the shift. The powder level in the powder tub is sensed by a capacitive-type proximity switch.

6. Tamping Station:

The product to be filled is fed from the hopper to the dosing disc. Due to the centrifugal force of the dosing chamber drive the product is carried to the outer edges of the dosing disc to the tamping plungers. The product is then compressed five times before being transferred into the capsule.

7. Pin Plate Assembly:

This consists of a plate on which various segments of pin for different applications are fitted. At No. 5 unopened capsules are collected in a box which are ejected out by pins. Similarly at stations 6,7& there are pins for the closing of capsules ejecting the capsule from the exit chute and cleaning of the capsule. 

8. Electrical control assembly:

This electrical control panel is mounted inside the structure of the machine. The mains ON / OFF switch is on the cover of the machine. The drive ON / OFF, control ON, speed regulator, and the emergency OFF. Switches are mounted on the pendent of the machine. Inching facility is provided for easy checking of the various settings on the machine. The display screen of the PLC has various selector keys for performing various operations. The control cabinet inside the structure houses the AC drive, The PLC, MCB`s contractors, and overload relays.

  PLC Description:

The main function of a PLC is to translate the instructions into the digital codes needed to operate the device or machine & to collect data from field instrumentation & display the information on the operator station. The instruments are connected to the system equipment. The collected data will be utilized by the PLC process control. The user interface, based on an industrial-type MMI. Will assist the operator in supervising and controlling the process. Based on the displayed information the operator, utilizing the user interface, can provide commands to the PLC. The PLC then executes the operator’s instructions. A Mitsubishi family FX 2 N 32 MT ESS PLC has been the central processing unit (CPU).

The PLC system layout for the automatic capsules filling machine automation is as shown below:

Related: Auto Coater Installation Qualification Protocol/ Annexures

Reviewed By:

Date

5.13 Annexure(s):

6.3 FINAL REPORT APPROVAL

Includes your Final Report Approval here.