Site Acceptance Test Protocol for Tablet Compression

Site Acceptance Test Protocol for Tablet Compression

machine name : FALCON B4 TYPE 35 STN “B” TOOLING TAB, MACHINE
Client Name & address : FALCON, AHMEDABAD, INDIA
document name : SITE acceptance test PROTOCOL
PROTOCOL no. :
Revision no. : 00
MACHINE SR. NO. :

Table of contents

Sr. No. Title Page No.
1.0         Approval Sheet
2.0         Purpose
3.0         Scope
4.0         Responsibilities
5.0         System description
6.0   SAT Procedure
7.0            Deficiency & Corrective Action Report
8.0            SAT Summary, report and Certification of SAT
  • 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 Tablet Compression B4 Type 35 Station. “B” Tooling Tab, Machine is delivered at pharma Company without any discrepancy along with appropriate documents.

  • SCOPE:

The Scope of this document is applicable to perform the Site acceptance test of Tablet Compression B4 Type 35 Station. “B” Tooling Tab, Machine. Tablet Compression machine is to be installed at pharma company.

  • RESPONSIBILITIES:
    • Engineering:
      • To prepare and review of Site acceptance test document.
      • To execute the SAT activity.
  • 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 :

The major components of the equipment are identified us:-

  • Powder Feeding unit.
  • Powder transfer unit
  • Compression unit
  • Hydraulic power pack assembly
  • Discharge unit
  • Lubrication unit

The Tablet Compression B4 Type 35 Station. “B” Tooling Tab, Machine, supplied by FALCON., a double rotary high speed tablet press, is a machine in incorporated with the force-feeding arrangement, auto-lubrication, electromagnetic clutch, power level sensor and rejection / sampling port.

Powder feeding unit has S.S. 316 Hopper of capacity 16 Liters. rests on top of the machine which holds the powder in it and delivers to the feeding assembly through a butterfly valve which control the flow of the powder between the hopper and the feeding assembly. The hopper consists of an agitator, which enhanced the powder flow. A barrel –type powder level sensor is mounted on a bracket and fixed against the sight glass of the hopper.

Powder transfer unit Consists S.S. 316 inlet connector, which links the hopper and the force feeder, the force feeder has two counter rotating paddles of S.S. 316, driven by reduction gearbox and variable frequency AC drive motor. The tail over die is an essential feature of the high – speed tablet press. The function of the tail over die is to keep the filled die covered until the last moment before the upper punch enters the die.

Drive unit has main motor of 5HP drives a very high reduction gearbox unit using an electromagnetic clutch and a timing belt. The gearbox unit consists of a Phosphorus bronze worm wheel and a worm shaft. Turret is a three piece structure having the center die tablet of S.S. 316 and upper and lower piece of cast iron of SG 400/15. The upper piece holds the upper punches, which rests on the upper cam tracks with the cam plate. Similarly, the lower piece holds the lower punches that travel on the lower cam tracks and Dozer.

Compression unit comprises upper main pressure roll assembly having a roll centre, pressure roll and pressure roll pin. The roll centre holds the pressure roll and is locked by using external circlips upper punch penetration assembly is responsible for the entry height of the upper punch in the die. Tablet thickness assembly is responsible in deciding the tablet thickness.

Weight dozer assembly is responsible for adjusting the weight of the tablet by varying the depth of fill. The depth of fill is adjusted by the upward and downward movement of the weight adjusting head through a dozer adjusting screw with the help of dial.

Hydraulic power pack assembly system control the safety overload mechanism, which governs the maximum pressure, level, at which particular tablets are being made. The oil reservoir for this system is located in front LH corner within lower cabinet. It can be accessed by removing the lower side guard (LH). The oil level in the reservoir should be checked regularly through the oil level indicator.

Tablet discharge unit comprises of ejection cam, tablet scrapper assembly & tablet discharge chute. The height of the ejection cam needs to be set in such a way that the tip of the lower punch is slightly above the die so as to avoid tablet-chipping problem. As soon as the tablet is ejected out it strikes the tablet scrapper assembly, which directs the tablet to the discharge chute. Tablet discharge chute is made S.S. 316 with acrylic cover. Tablets slide out through this chute to the container.

Auto lubrication system provided for the lubrication of all critical pinpoints like roll pins, it comprises of a lubrication tank, a motorized pump, distribution manifold and pipelines. This pump operates on timer set in the PLC. It should be noted that the ON time should be less then the OFF time, to prevent the oil flooding. The dozing of oil respective critical points can be throttled through the distribution manifold.

Lower punch lubrication system helps mainly for smooth and easy ejection of tablets. In addition the tablet gets a clean, smooth surface at the web. The lower punch has an extractor groove below the tip for the lubrication support, which may be a lubrication felt or woolen thread winding. In order to avoid lubricant, the scraper mechanism is built in. the stripper oil is collected in a collecting tray. The scraper keeps the external diameter of the die plate and lower punch guide clean. From the collecting tray the oil is transported downward through a funnel and a hose line and returned back into the tank.

The working principle of compaction force control is whenever the powder is compressed to from a tablet an impact is generated. The oil in the hydraulic cylinder absorbs this impact. The load cell, which is mounted between the upper roll lever and the hydraulic cylinder, senses the load received. The value is transferred to the data control screen through the MP55 transducer and the PLC. The data control screen displays the individual force of all the punches. 

  • SAT PROCEDURE:

Falcon, Ahmedabad, India representatives have performed SAT at the Pharma Company.after delivery of Tablet Compression B4 Type 35 Station. “B” Tooling Tab, 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(EG): 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

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