• April 20, 2024

FAT in pharmaceutical industry is performed at the equipment’s manufacturer facility to verify the equipment’s performance before transporting it to the buyer’s site.

FAT in pharmaceutical industry consists of a series types of acceptance tests performed at the equipment manufacturer’s facility before shifting the equipment to the buyer’s location. Its basic purpose is to verify the machine’s entire performance according to the agreed specifications. The equipment is operated in real-time, with actual operating conditions in the buyer’s facility.

FAT in pharmaceutical industry is an integral part of equipment commissioning. It helps to detect any shortcomings or problems with the manufactured equipment before being shifted to the buyer’s facility.

FAT in pharmaceutical industry is performed at the commissioning stage of the equipment life cycle. The position of FAT is after the planning and design approval stage. It is performed when the equipment has finally been manufactured by the equipment manufacturer before transporting it to the buyer’s facility.

FAT in the pharmaceutical industry is the first step of the commissioning stage. After performing and approving FAT, the next step is Site Acceptance Test – SAT, which is performed at the equipment’s buyer location.

What are the acceptance test criteria for FAT in pharmaceutical industry?

Acceptance criteria for the factory acceptance test in the pharmaceutical industry are the desired outcome from equipment. These are finalized during the design phase and are indicated in the User Requirement Specification document. The URS is a document against which acceptance criteria for entire commissioning and qualification activities are defined.

FAT in pharmaceutical industry is performed by

Commonly, FAT in pharmaceutical industry is performed by a team from the following departments.

Engineering department: they are responsible for critically analyzing the equipment and checking whether there are any design or manufacturing faults.

Quality department: the quality department is responsible for checking if any deviation is related to quality principles. 

Production department: a representative of the department where the equipment will be installed. It’s best to include personnel with firsthand equipment operation experience, for example, machine operators or area supervisors. 

 Template for FAT in pharmaceutical industry

There is no fixed template for FAT in pharmaceutical industry. It depends on the mutual coordination of the buyer and manufacturer to decide on the FAT template.

Typically template for FAT in pharmaceutical industry consists of a tabular form with specific columns. The columns indicate the respective section as mentioned below.

Test Acceptance Criteria Pass / Fail Signature with date

 

The test is the desired test performed on the machine or a specific process . It also indicates a particular part, process, section, or function of the equipment to be tested.

Acceptance Criteria: it is the desired outcome of the test. Typically, it indicates the buyer’s requirements for which the equipment under test has been procured from the manufacturer.

Pass / Fail: This column indicates the success or failure of the test. If the outcome of the test fulfills the acceptance criteria, the test is considered a pass, and the same is indicated/written in this column. On the other hand, If the outcome does not fulfill the acceptance criteria, the test is considered a failure, and the same is indicated/written in this column.

Signature with Date: This column includes the signature of the personnel performing the test. Its main purpose is to make sure that the acceptance test is performed with full responsibility.

 Checklist for FAT in pharmaceutical industry

 

FAT in pharmaceutical industry
FAT in pharmaceutical industry is performed at the manufacturer’s location to identify faults before transporting the equipment to the buyer’s location

 

There is a separate checklist for every piece of equipment,, and it depends on the specific process for which the buyer has bought the equipment.

Following is a generalized checklist for factory acceptance tests, which covers common equipment tests. You can take the checklist as per your requirement and omit those not required or included in your equipment.

Machine Capacity

In this test, the equipment’s working capacity is verified. It includes verifying that the machine can produce the output at desired speed or capacity. The output capacity can be termed in pieces/hour or the rpm.

Test Acceptance Criteria Pass / Fail Signature with date
Operate the machine at the desired speed The output pieces / hour should be ____

Or

The output should be _____ kg/hour

Or

The machine speed should be ___ rpm

Output product condition The output product should be in good condition without breakage.
Labeling The labels at the product should be satisfactory without any

·          Duplicate labels

·          Over glued labels

·          Under glued labels

·          Misplaced labels

·          Missing labels

 

 

Software

In this test, software systems are verified and checked whether the manufacturer has included all features for which the buyer has paid the price.

Some common test in this section includes the following.

Test Acceptance Criteria Pass / Fail Signature with date
Login ID & Password ___levels of password protection have been provided

 

Options of one level cannot be accessed by another level

21 CFR part 11 Software should follow the guidelines of United States FDA, CFR part 11
Graphical data All critical data ( provided by the buyer during design phase) should be graphically displayed
Data backup Software is capable of backing up the data every after ____ time or user defined time

 

Human Machine Interface – HMI

In this test, the Human machine interface is tested. It includes verification that HMI is installed according to the buyer’s requirements and contains all the functions, applications, and systems.

Some common tests related to HMI include the following

Test Acceptance Criteria Pass / Fail Signature with date
Power Supply HMI is powered-up by 24VDC/ 220VAC / 110VAC
Main screen When HMI is powered-up, main screen appears
Touch Panel Touch system works efficiently without any system hang

 

Touch panel is in satisfactory condition without any breakage

 

Utility Connections

In this test, utility connections are verified. The main aim of this test is to make sure that the equipment is capable of providing the required performance at the specifications of the utility connection available at the buyer’s location

Some common tests related to utility connections are mentioned below.

Test Acceptance Criteria Pass / Fail Signature with date
Steam ·          Machine must operate satisfactorily at ___ steam

 

·          Regulator for steam must be provided

Compressed Air ·          Machine must operate satisfactorily at ___ bar

 

·          Filter for oil must be provided

 

·          Filter for moisture must be provided

Water Machine must operate satisfactorily at ___ bar
Particular (Gas) Machine must operate satisfactorily at ___ bar

 

Instrumentation

In this test, all instrumentation system is verified. They are checked for accuracy and performance. It is also checked that the manufacturer has installed instrumentation for all the systems and processes as required by the buyer

Some common tests in the instrumentation includes the following

Test Acceptance Criteria Pass / Fail Signature with date
Instrument

(temperature / pressure/ airflow / level / counter  conductivity / TOC  pH values / chlorine /   etc. etc.

The instrument must be properly wired without any losing in its connections and terminals.
The instrument values must be free of any fluctuations
instrument should measure and display their respective values of ___ process

 

Materials of Construction

In this test, materials of construction for various parts are verified.

Some common tests in the instrumentation include the following

Test Acceptance Criteria Pass / Fail Signature with date
Product contact parts Product contact parts must be of SS316L
Non – product contact parts Non product contact parts must be of SS304

 

Operating parameters

The equipment’s various operating parameters are checked and verified in this test. These tests are essential because output depends on the operating parameters.

Some common tests related to operating parameters include the following.

Test Acceptance Criteria Pass / Fail Signature with date
Flow rate The fluid flow rate should be _____
Mixing speed The mixing speed should be variable with minimum speed ______

And maximum speed _____

Heating The equipment must provide heating for temperatures up to _____
Vacuum Vacuum system must be installed

Vacuum system must provide vacuums upto

cooling Cooling system must be installed

Coling system must provide vacuums upto

 

Environmental parameters

The equipment’s ability to provide specific environmental conditions is checked and verified in this test. These tests are mostly performed for HVAC or its related equipment such as Cleanrooms and Pass throughs

Some common tests related to Environmental parameters include the following

Test Acceptance Criteria Pass / Fail Signature with date
Temperature The system must provide temperature conditions in the range of _____
Relative humidity The relative humidity must be in the range of ______
Particle Counts The particle count must be in the range of _____
Differential pressure Differential pressure across ______ area must be in the range of _____
Air change rate Air changes  must be in the range of _____
HEPA filter HEPA filter of class _____  must be installed at the ____area

 

Certificates HEPA filter must be provided

 

Documentation

In this test, it is verified that the manufacturer has provided all the documentation. The documentation format is also approved and contains all the necessary information.

Some common tests related to documentation include the following

Test Acceptance Criteria Pass / Fail Signature with date
User Manual Clear instruction for the equipment user indicating how to operate the equipment in a way that produces satisfactory prduct
Validation Documents ·          Design Qualification

·          Installation Qualification

·          Operational Qualification

·          Performance Qualification

Calibration certificates ·          Material of construction

·          Surface finish

·          HEPA filters

Software design specification Should be provided
Hardware design specification Should be provided
Drawings ·          Equipment layout indicating installation requirements

·          Process & instrument diagrams

·          Spare parts list

·          Electrical diagrams

 

Operational Test

  • After individual functions have been tested and verified, equipment is operated for a single cycle or any number of cycles ( as per agreement)
  • In this test, actual production parameters are applied, such as temperature, pressure, and speed
  • Define acceptance test for every equipment function and cycle
  • Operate every single function or process parameter.
  • Note down the result, as mentioned in the format above.
  • Finalize the document with respective signatures.

 

Report for FAT in pharmaceutical industry

After completion of the FAT in pharmaceutical industry, a detailed report is prepared. Its main purpose is to document the entire FAT activity for record purposes and future follow-up.

There can be different formats for factory acceptance tests, but it is necessary to include all the relevant information and data in it.

Typically report for FAY consists of the following information and detail

  • Deviation in the equipment design, working or in its output product
  • Identification of corrective actions
  • Responsibility of the equipment manufacturer
  • Responsibility of the equipment buyer
  • Corrective actions required
  • Timeline of the corrective actions
  • Timeline for next FAT or SAT

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