URS of Tablets Automatic Coating Machine

User requirement specification (URS) of Tablets Automatic Coating Machine

User requirement specification (URS) of Tablets Coating Machine is a list of all the requirements from the user, After the preparation of the list, the documents are sent to the manufacturer to get the required materials as per the given criteria.

The user department will raise the indent for his requirement regarding the Coating machine. Will give all the requirements in the format of URS, which include the functional and technical specifications for the Coating machine. All the specification in the written format is defined below.

  • General
  • Salient Features
  • Operational Requirements
  • Utilities
  • Maintenance
  • Inspection and Testing
  • Commissioning and Documentation
  • Training
  • Packaging
  • Deviations
  • Delivery

1. General Information of Coating Machine:

It contains Following Information

Equipment ID – To be embossed /imprinted conspicuously on the equipment

Description – The equipment shall be used for coating of different shape and size of tablet with different coating solutions.

Use of Equipment – The equipment will be used primarily for coating of the tablets of different sizes and shape.

Field Identification –

To be installed in Tablets block.

Allocated floor space for the equipment to be specified by supplier with a clear ceiling height of 3.2 m Approx.

  • Room Temperature NMT 300C and RH less than 60%
  • Non-flame-proof area

2. Salient Features of Coating Machine

General requirement

  • Unit to be compact with ease of operation.
  • A closed system with minimum dust generation
  • Ease of maintenance
  • Easily cleanable with minimum recesses and crevices.
  • All welded joints to be grinded where the product may be in contact to smooth finish and lead-free.
  • All gaskets provided to avoid leakages should be amenable for easy removal and re-fixing,
  • All electrical/pneumatic parts should be pre-wired.
  • Convenient lubrication design
  • Complete safety interlock design
  • All bolts and nuts on the exterior part of the equipment are preferable with a cap head or cap nut.
  • Parts which are required for cleaning should be provided with a quick fixing arrangement

Material of Construction –

All the contact parts should be of SS 316L and non-contact parts preferably of SS 304. SS 304 lining over entire booth base frame including electrical panel.

Finish – Contact Surface Finish Matt./Mirror

Electrical Construction – Non-flameproof.

Operational requirement –

Neocota is a complete system having all the basic sub-systems necessary for Automatic Film and Sugar Coating for Tablets. The basic sub-systems will be required as under

  • Coating PAN and PAN Cabinet.
  • Spray Unit
  • Hot air unit with three-stage filter and dehumidifier unit
  • Exhaust Unit
  • Liquid Feed vessel Unit
  • Control Unit
  • Loading
  • Tablet Unloading Device
  • Clean in-place facility
  • Safety features for Aqueous film coating

There shall be three coating Pans that are interchangeable.

Coating Pan shall be perforated.

  • PAN speed shall be 2 – 12 rpm (supplier to specify).
  • PAN shall be coupled with an AC drive (Variable drive).
  • PAN shall be air-tight and bottomless construction from the outside.
  • PAN edges shall be rounded.

Coating pan requirement:

  • One pan (supplier to specify), specifically for this machine only
  • Pan Dia (supplier to specify)
  • Pan mouth Dia (supplier to specify)

Control

  • Through PLC
  • PLC based with minimum following features :
  • Recipe management (Number of recipes required more than 500)
  • Initial ON/OFF starter with the emergency stop of inching facility
  • Temperature / RH of air.
  • Airflow in CFM
  • Time-based functions.
  • Product screen delta pressure.
  • Filter chamber delta pressure.
  • Solution spray rate.
  • Pan RPM.

Power failure/recovery

In the event of a power failure, the system shall protect the 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 to re-start

Emergency stop –

The emergency stop mechanism(s) shall be located in easily accessible areas around the equipment as a requirement of safety precautions.

4.Utilities :

To provide utilities at ONE POINT is the user’s responsibility. Supplier to give details and drawings for exact size, location, type, capacity, etc. of the utilities required.

5. Maintenance :

The supplier should provide the following maintenance instructions,

  1. Operation and Maintenance manuals along with as-built drawings
  2. Lubrication instructions
  3. Daily checks on the machine
  4. Cleaning procedures

6. Inspection and Testing:

Equipment shall be inspected and tested by the user at the supplier’s factory with respect to DQ prepared by the Supplier and approved by Company.

In order to verify system performance, the User shall witness the execution of the Factory Acceptance Test procedures.  The Supplier shall notify the User two weeks in advance of the start of this test.

The Factory Acceptance Test Specification shall be submitted to the User for review and approval prior to execution.  A minimum of two weeks shall be allowed for the User to review and comment and/or approve the Factory Acceptance Test Specification.

7. Commissioning and Documentation :

  • IQ/OQ/PQ to be completed by the supplier along with Company representatives.
  • The Supplier to demonstrate the performance of the machine at the User site as per agreed terms.

The Supplier to submit the following certificates:

  • Calibration certificates of all the instruments used have traceability to NPL / NIST
  • Performance certificates of Tests conducted at manufacturer end for Motors / Gear Box / Fan and other critical bought-out items with Serial nos.

Development:

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

Also, the following documents shall be supplied in soft (MS Word & AutoCAD) as well as hard copy

  • Functional specifications/requirements
  • Design Specifications
  • Controls tests
  • Operational tests
  • Factory Acceptance test
  • Operator Maintenance and service manuals
  • Process, and instrumentation diagram (P & ID)
  • Instrument listing
  • Control schematics
  • Control panel assembly drawings
  • Equipment Assembly Drawings
  • Spare part list
  • Hydro test reports
  • Filter’s specifications and certificates (Wherever applicable).

8. Training:

Start-up support

Supplier to train the respective technical associates of the Company on operation, maintenance, and cleaning of the equipment wherever applicable.

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 the user of any improvements)

9. Packaging:

Supplier to specify packaging of machine for safe transportation and delivery at the site.

10. Deviations:

Any deviation from URS shall be highlighted

11. Delivery:

As per the purchase order.To be delivered

 

About Pharmaceutical Guidanace

Alice is the Author and founder of pharmaceutical guidance, she is a pharmaceutical professional having more than 18 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube

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