Site Acceptance Test Protocol for Blister Pack Machine
| machine name | : | BLISTER PACK MACHINE. |
| Client Name & address | : | M/S BLISCARE MACHINES, MUMBAI. |
| document name | : | SITE acceptance test PROTOCOL |
| PROTOCOL no. | : | |
| Revision no. | : | |
| MACHINE SR. NO. | : |
Table of contents
| Sr. No. | Title | Page No. |
| 1.0 | Approval Sheet | 03 |
| 2.0 | Purpose | 04 |
| 3.0 | Scope | 04 |
| 4.0 | Responsibilities | 04 |
| 5.0 | System description | 05 |
| 6.0 | SAT Procedure | 06 |
| 7.0 | Deficiency & Corrective Action Report | 07 |
| 8.0 | SAT Summary, report and Certification of SAT | 08 |
- APPROVAL SHEET:
Prepared by:
| Name | Designation/Department | Signature | Date |
Reviewed by:
| Name | Designation/Department | Signature | Date |
Approved by:
| Name | Designation/Department | Signature | Date |
- PURPOSE:
The Objective of this site acceptance test is to verify that the Blister Pack Machine at Pharmaceutical Industry without any discrepancy along with appropriate documents.
- SCOPE:
The Scope of this document is applicable to perform the Site acceptance test of Blister Pack machine is to be installed at Pharmaceutical Industry.
- RESPONSIBILITIES:
- Engineering:
- To prepare and review of Site acceptance test document.
- To execute the SAT activity.
- Engineering:
- Manufacturing:
- To review the Site acceptance test document.
- To Co-ordinate with engineering department during SAT activity.
- Quality Assurance:
- To review the Site acceptance test document.
- To Co-ordinate with engineering department during SAT activity.
• Head Quality/Designee
→ To approve the site acceptance test document.
- SYSTEM DESCRIPTION :
| Sr. No. | Description |
| The basic WEP3600 consists of the following sub assemblies: | |
| I | Structure Assembly The structure is enclosed on three sides are closed by frame and only back side covered with removable doors. Removing the knob side to access the machine back side assembly and Control Panels. The filter regulator for Main air inlet, dial Pressure Pneumatic solenoid valve assembly and Induction Motor with Worm reducer Gear Box Geared Motor for main drive assembly. Pack transport conveyor assembly.. |
| II | Forming Station Assembly This consists of the main shaft with water jacketed housing and Vacuum, Vacuum ring assembly, Blister forming roller mounting main shaft with locking long Blot. Adjusting with forming roller assembly the Contact heater assembly will be there for Uniformly producing heat and transferred the same amount of heat to the forming foil to get Form the cavity uniformly. |
| III | Feeding Station Assembly This assembly consists of Variable vibration controlled Linear Vibrator assembly with Product Hopper and Universal Feeding Box with Feeding channel mounting holder. Below the Feeding Channel mounting assembly the dust collection point. |
| IV | Guide Track Assembly The Guide track assembly has 3 pieces of Guide Track length of 405 mm with Impression plate assembly before sealing station |
| V | Sealing Station Assembly The sealing station assembly with the Counter sealing roller mounting shaft with cylindrical lock nut and pressure sealing roller mounted shaft. The drive side of Sealing station has a pneumatic cylinder for control the sealing pressure with flow control knob. |
| VI | Linear Indexing Station Assembly This consists of Linear Pusher assembly with eccentric stroke adjustable assembly with tie rod. The pusher assembly mounted on Linear indexing platform. Suitable size pusher use to fit in the assembly. |
| VII | Punch Station Assembly This assembly consists of Punch Tool mounting assembly bracket and four mounting pillar for tool mounting Punch Tool Assembly. The Punch tool assembly has punch guide plate so called as stripper plate, which guide the sealed web to punch and die plate. After punched the Blister strip the excess Trim will get cut by trim cutter blade mounted in punch tool assembly. |
| VIII | Pack Transport Conveyor Assembly The Pack track Conveyor assembly consists of endless conveyor belt with beck support conveyor. The conveyor basic drive connected with main machine drive to get a synchronize speed of conveyor for maintain the conveyor speed. |
- SAT PROCEDURE:
M/S Bliscare Machines, Mumbai. representatives have performed SAT at the Pharmaceutical Industry. After delivery of Blister Pack Machine recorded all the data in the prescribed SAT checklist as per details given below:
- Design SAT Verification Check list:
| Sr. No. | Description | Acceptance Criteria | Observation | Complies/Does Not Complies | Checked by(E G): Sign/Date |
| 1. | Purchase order | Should be available. | |||
| 2. | Installation, Operational and maintenance manual | Should be available. | |||
| 3. | Qualification documents | Should be available | |||
| 4. | Component Packing | All the component should be packed properly to avoid any damage during transportation. | |||
| 5. | Any physical damage to the equipment | No physical scratches or damage should be observed. |
- Deficiency & Corrective Action report:
In case there is any deficiency followed during stage of SAT, corrective action should be taken and same shall be recorded as given below:
Description of Deficiency (an extra sheet can be used if space is insufficient)
Raised by……………………
(Sign/date)
Corrective Action :( an extra sheet can be used if space is insufficient)
Approved By:
| Name of the Person | ||
| Sign | ||
| Date |
- SAT Summary, Report and Certification of SAT:
………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
Certificate of Site Acceptance Test
This is to certify that the ___________________________________
Has successfully completed the Site Acceptance Test.
This Site Acceptance Test has been performed by:
| Sr. No. | Name | Department | Designation | Sign/Date |
| 1 | ||||
| 2 | ||||
| 3 |