1.0 APPROVAL

The user requirement specification for Automatic Capsule Filing Machine for filling the bulks of capsules which is to be used in Production Area have been prepared, reviewed, approved & authorized by concerns from the following area.

2.0     Scope:

The URS document is generated by the User to provide details of structural, functional, cGMP and statutory requirements for the Automatic Capsule Filing Machine in order to obtain information and technical offer from different vendors.

To provide a written document to vendor with respect to correct design of equipment as per requirement.

This specification covers the design, manufacturer, inspection, testing and commissioning of Automatic Capsule Filing Machine, together with supporting documents of the equipment to be used in Production area (for filling the bulks of capsules). This design must comply with cGMP requirements.

This URS will be recognized as an integral part of the procurement agreement with the selected equipment Manufacturer. The equipment shall operate under controlled environment (ISO-8) and conditions as per the GMP requirements.

3.0    Process / Product Requirement:

3.1    Name of the equipment: 

Automatic Capsule Filing Machine

3.2 Purpose of Equipment:      

The purpose of Automatic Capsule Filing Machine is to do fill a set amount of medication or pharmaceutical ingredients into the capsule.         

3.3 Chemical/Physical Characteristics of the Process Material:

Not Applicable.

3.4 Suggested Capacity:                     

Equipment Capacity- 25,000 Capsules/min.

4.0  Operational Requirement:

4.1    Equipment Description

The Automatic Capsule Filing Machine is used in pharmaceutical industries for filling the bulks of capsules. The capsule filling machine automatically ejects the capsule which is filled and locked in the machines. Automatic Capsule filling machine automatically fills the capsule by the dry forms of powders.

4.2    Technical Requirements:                                            

Equipment Name

Automatic Capsule Filing Machine

Equipment Capacity- 416 Capsules/min. Or, 25000 Capsules/min.

Suitable for Capsule Size-00 to 5 #

Filling accuracy within + 3-5% depending upon products

Sr. No

Item

Specifications

1Capsule Filing Area Dimension3.8 x 3.4 x 2.7 ( LxWxH) mts
2Temperature22±3 °C
3PressureAtmospheric
4Humidity40 – 60 %
5Motor & Blower FanExplosion Proof
6ElectricalsExplosion Proof
7HMIWater Proof

Standard major components:

Sr. NoOperationSpecifications
1Automatic Transfer systemTransfer system for empty capsules and powder is an essential part. This unit conveys these materials to their hoppers without manual handling and can reduce labour costs and material waste. It can be automatic or in manual mode.
2Hopper of Filling machine (For Powder or Empty capsule)This capsule filling machine part is equipped with level sensors to detect and alert the low or high levels. It precisely controls the material flow into the feeding unit and when it’s running out of capsules or powder, the machine should stop immediately.
3
Capsule Feeding Unit
When empty capsules flock in from the hopper, this unit orients the capsules then, it nudges and aligns them into the segment bores and after that next step is separation (body and cap) of Empty capsules.
4
Powder Dosing and Filling System
It is loaded with a level sensor to control filling accuracy while reducing material waste. It works with a fixed or height-adjustable dosing disc to complete the filling process and this unit can regulate the tamping force to prevent capsule breakage.

General Requirements for Components

Tamping Pin:
  • It is these pins that compress material at different stages to a predetermined depth. Filling rod presses the powder in 5 different stages.
  • In each stage, it presses the powder/pellets to a predetermined depth. That is, the depth of compression decreases as you move towards the ejection stage.
Capsule Filling Machine Dosing Disc:

It controls weight and ensures consistent dosing of powder.

Closing and Discharge:

These assemblies should be easy to detach and fit depending on capsule filling requirements. It is the discharge part that prevents possible vortex when capsules leave the tooling system.

Mechanical Drive System:

The design and configuration of automatic capsule filling machine create linear, rotary or oscillatory motion depending on the design of the mechanical drive system. All the moving parts in a capsule filling machine depend on a mechanical drive system. This is in the form of mechanical motors that create motion to move gears and conveyor systems.

Vacuum Loader:

Must have two vacuum loader system on the capsule and powder side. It ensures that the capsules and powder/pellets enter the appropriate hoppers for further processing. This system separates empty capsules and quickly cleans the segments for the next circle without manual intervention.

Metal Detector:

  • could separate the metals in the raw materials
  • Ensure high quality levels by removing contaminated capsules.

Dust Collector

A high-efficiency dust collector should be installed along with the machine.

Capsule Polishing Machine:

The capsule polishing machine remove the dust and static electricity on the surface of capsule and improve the surface smoothness. The capsule polishing machines ensure the capsule surface remains clear with the right texture and color. The Capsule Polishing Unit consists of a spiral brush with teflon net, deduster with suction blower and powder collection chamber. The filled capsules are passed through a spiral brush, which removes the powder from the capsule surface. The loose powder is sucked by the suction blower attached to the polishing brush and is collected in the powder collection chamber.

Transfer Pipes (Required as Optional)

  • Pharma grade transfer pipes.
  • Ensure smooth product transfer.
  • Should not collapse during transfer.
  • Easy to clean

WIP System

  • WIP system with the following options,
  • Purified water
  • Raw water
  • Cleaning spray balls should be installed for cleaning product trolley, drying chamber & filters.
  • WIP should be so efficient that no manual scrubbing is required.
  • Platform & stairs with side support.

 HMI & PLC

  • HMI (Required brand)
  • PLC (brand).
  • Color screen with a sensitive touch system.
  • Waterproof HMI & PLC.
  • Software installation for PLC & HMI.
  • Display of the following parameters on HMI
    • Number of capsules Filled
    • Speed of machine
    • During Operation visual diagram of working components

4.3 Material of Construction:

Sr. NoComponentsSpecifications
1All Contact PartsSS 316L or SS316
2Non-Contact Parts.SS 304L or SS304

4.4    Details of Utilities :                         

  • Electric Power Supply/Voltage:  4 Kilo watt / 415 Volts,3Phase,50Hz
  • Compressed Air Pressure:  4 CFM

4.5 Software and Hardware

As per the GMP designed.

4.6    Preferable Method of Cleaning:

Easily accessible for cleaning.

Product contact parts shall be easily dismantlable and cleanable

All contact parts to be cleaned with water.

The equipment shall be compatible to different cleaning agents

Parts which are required for cleaning should be provided with quick fixing arrangement.

5.0 Safety Requirement:                               

5.1  Process Safety Systems/Alarm and safety features:                            

  • Hopper powder sensor.
  • Low air

6.0   Documentation Requirement:

The manufacturer will provide Documents including the following,

  • IQ, OQ, PQ Document
  • Manual for Equipment
  • Maintenance Manual
  • Instructions
  • MOC certificate
  • Make and model info.
  • Electric wires & panel diagrams.
  • List of all parts & spare parts.

7.0 Compliance & Data Recording

  • Capsule Filling machine must be compliant with all regulatory bodies including 21 CFR.
  • HMI must store sufficient product data.
  • Data printing option.
  • Data backup.
  • Data transfer by USB.
  • Password protection & audit trail.

8.0 Scope of Training:

  • The Manufacturer shall provide operator training at site. This shall include, but not limited to, making available the services of a qualified representative to train the operators.
  • The training of the personnel shall include a minimum of the following:
  • Start-up and shut-down procedures
  • Typical operations
  • Emergency shutdown
  • Safety training
  • Troubleshooting procedure
  • The Manufacturer shall ensure that the operation manual is available at site for reference. The Manufacturer shall issue certificates to the persons trained by them after successful completion of training at no extra cost

9.0 Abbreviations:                                       

IQ               Installation Qualification

cGMP        Current Good Manufacturing Practice

OQ             Operational Qualification

MOC          Material of Construction

PQ             Performance Qualification

PLC           Programmable logic controller

SS              Stainless Steel

CFM          Cubic Feet Per Minute

10.0 Discussions/ Reviews/ Comments:

The user requirements specification is prepared for communicating the user expectation for the subjected equipment manufacturer/supplier with respect to the subjected equipment. The requirements specified are the basic requirement based on the available information for the process, operation, safety and cGMP requirements. The vendor is encouraged to suggest and/or quote for the latest developments to increase/improve the productivity, product quality, process control, safety etc.