Site Acceptance Test SAT is the document widely used document in every pharma industry. The SAT is a key input to the installation and commissioning of equipment as per VMP. After OEM understood the user requirement specification (URS) his team generate the design qualification (DQ) document and factory acceptance test done & submit this to the pharma organization. Then, when the machine is delivered at the pharma organization site, SAT will be done & if it is found in compliance further processes will be started like the installation of equipment. This also leads to verification that the proposed design of the facilities, systems, and equipment is suitable for the process and meets all regulatory requirements as per our URS.
After reviewing this design document, we assured that the design deliverables are consistent with the URS and mitigate all control and process strategies.
Or SAT refers to be done when the system is put in its permanent functioning position, a Site Acceptance Test (SAT) is carried out at the location, offering the chance for last-minute confirmation.
An SAT is responsible for testing and verifying functionality with other interfaces on-site in accordance with test plans and requirements set by the customer and making sure nothing was altered or harmed during shipping and installation.
SAT document has the following tests:
- Finishing visually verified.
- Primary elements visual inspection.
- Pressure and ventilation settings inside the box.
- Checking the settings and operation of utilities
- Verification of Interlocks and Functionality (Mechanical & Software).
- Test the hot dispensing system (activity source supplied by Customer).
- Checking the dosage calibrator (activity source supplied by Customer).
- Check the interlocks and safety devices.
- Operator’s training.
- Delivery of the performed FAT protocol and documentation package.
- Performed FAT Protocol.
- User guide or User’s manual.
- List of suggested spare components.
- Declaration of Compliance.
- Technical drawings for as-builts (electrical, mechanical, pneumatic & process schemes).
- data sheets and certificates for materials.
- Main equipment data sheets.
- Calibration certificates.
Approval of SAT document:
The protocol is approved by all stakeholders like the User, engineering, Quality control warehouse department, etc., and finally approved by the Quality assurance department.
Approved By: Name: Position: Signature: Date:
Scope:
SAT document applies to the machine which will be supplied by OEM as per URS provided by the pharma organization.
This document contains all information and data necessary for the hardware and software with all components used in the machine and the acceptance test according to the Life Cycle Model (GAMP).
RESPONSIBILITIES:
Pharma Company:
To Check and Approve the design qualification document.
Original Equipment Manufacturer (OEM):
- Design, installation engineer, and give all technical information of the equipment in the design qualification, i.e.
- Machine overview,
- P&ID drawing,
- Equipment orientation with layout,
- Specifications of the purchased items, including manufacturer, model, number, backup documentation, and brochures.
- Details of Utility details.
- Identification of components for calibration
- Material of construction of all components
- Safety features and alarms
- To assist the client in setting up the machine’s Factory Acceptance Test at their workplace or location.
- SAT verify that the equipment was delivered to the user site safely.
The following equipment details shall be verified:
| Sr.No. | Description |
| 1 | Physically verify various components as received in the packaging list (Attach a copy of the packing list) – Are all components available as per the packing list? |
| 2 | All component’s physical conditions are found satisfactory. |
| 3 | All the welding joints on equipment/ system surfaces are ground to a smooth finish and meet the requirements as per User Requirement Specifications. |
| 4 | Equipment pre-installation cleaning is done and cleaning concludes that no foreign objects are left over on equipment/ system surfaces. |
| 5 | All the required spares/components are received and made available for installation as per the packing list from the supplier |
| 6 | All the related drawings (GA, Electrical, and others), and operation manuals are provided by the supplier for installation |
| 7 | All prerequisites for shifting the equipment into the area of use are fulfilled. |
| 8 | Men and machinery for shifting equipment are available. |
| 9 | Sufficient room for installation is provided. |
| 10 | Equipment position markings done as per drawings |
| 11 | Foundation for equipment installation made as per manufacturer’s recommendations. |
| 12 | The area is cleared for the installation of the equipment and its components |
| 13 | Proper measures have been taken to contain the dust generation operation while civil activity and installation of the equipment/ system. |
| 14 | All Supporting utilities(Electrical, Pneumatic, Steam, Hot water, etc. whichever is applicable) are identified as required. |
| 15 | The installation quality of utilities was found satisfactory and is as per the manufacturers’ recommendations. |
| 16 | Hazardous situations if any while installation is identified and personnel are trained about handling techniques |
| 17 | Identification and verification of safety installation of Mechanical / Electrical components is completed |
| 18 | Others, if any |
Final Approval:
Finally, SAT will evaluate and approved by all stakeholders,
- Technical SMEs,
- System owners,
- Any other stakeholders
- The document was finally approved by the Quality Head
Frequently Asked Questions:
If you want a draft copy or any other details about the Machine DQ, URS, FAT, or IQ please write us at: admin@flairpharma.com