Month: July 2021

Pass box Installation and Operational and Performance Qualification


Pass box is one of the clean room systems, which is used to transfer materials from one side to other side through controlled environment in order to avoid airborne cross contamination.

Pass box is used to transfer the material from lower cleanliness area to higher cleanliness area or vice-versa in the classified area and also known as the hatch. Pass box works as a barrier between two cleanliness level areas.

  Equipment Name :Pass Box
Equipment Model No.:KPB
Equipment ID No.:XYZ
Equipment Area :Dispensed Packing Material
Equipment Manufacturer Name :Envair Electrodyne Ltd.
Equipment Application:To transfer material from classified area to non classified area and vice versa.
Report  Date : 

REPORT APPROVAL:

 Prepared byChecked byChecked byChecked byApproved by
Signature       
Date     
Name     
DepartmentMaintenanceQuality AssuranceProductionHead -MaintenanceHead – Quality Assurance
  • OBJECTIVE:
    1. To provide the findings of installation, operational and performance qualification of Pass Box.   
  • SCOPE:
  • The report is applicable to Pass Box with equipment ID No. XYZ installed at Paithan site.
  • RESPONSIBILITIES:
    • Maintenance Officer/Executive: To prepare qualification report and co-ordinate the entire qualification activity.
    • Quality Assurance Officer/Executive: To witness the qualification study and ascertain that the study is conducted as per the protocol.
    • Production Officer/Executive: To execute qualification study in co-ordination with other departments.
    • Head Maintenance: To review the qualification documents.
    • Head Quality Assurance: To review and approve the qualification documents.
  • EQUIPMENT DESCRIPTION:
  • Refer page installation qualification protocol.
  • PROCEDURE :

Qualification of the equipment should meet the acceptance criteria outlined in the following steps.

  • Installation Verification Report
Sr. No.Check pointAcceptance Criteria (Specification)ObservationChecked by Sign/date
1.0Visual inspection of the equipment. Visually there should not be any abnormality.  
2.0Check the electrical cables for housing and anchoring.Electrical cables shall be securely housed and anchored.  
3.0Check the electrical ports.     All electrical ports shall be cleaned.  
  • Technical Specification Verification Report
Sr. No.Check  PointsAcceptance Criteria (Specification) *ObservationsChecked by Sign/date
1.0MakeEnvair Electrodyne Ltd.  
2.0ModelKPB  
3.0Indication lamp01 No.  
4.0Electronic buzzer01 No.  
5.0Tube Light02 Nos.  
7.0Limit Switch5 amps, 1 pols  
8.0Door interlocking solenoid coil10 mm stroke, 230 V AC  
9.0ApplicationTo transfer material from classified area to non classified area and vice versa.  
10.0Approximately Size (W x D x H)mm1300 (W) mm x 1100 (D) mm x 1400 (H) mm.  

* As recommended by the manufacturer

Sr. No.Check  PointsAcceptance Criteria (Specification) *ObservationsChecked by Sign/date
11.0Type of cleaningOn line  
12.0Sealing MaterialRTV sealant  

* As recommended by the manufacturer

  • Measuring Device Calibration Verification Report
Sr. No.Measuring DevicesAcceptance CriteriaInstrument ID No.Calibrated on Calibration DueObservationChecked by Sign/date
1.0MultimeterIt should be found within its calibration period.    
  • Utility Verification Report
Sr. No.Check  PointsAcceptance CriteriaObservationChecked by Sign/date
1.0ElectricitySingle phase, 230 V AC ± 10% and 50 Hz ± 5%  
  • Safety Features Verification Report
Sr. No.Safety FeaturesAcceptance CriteriaObservationChecked by Sign/date
1.0Edges / cornersEdges /corners shall be rounded.  
Sr. No.Safety FeaturesAcceptance CriteriaObservationChecked by Sign/date
2.0Electrical and electronic guardTotal enclosure for all electrical and electronic parts along with earthling shall be provided.  
3.0Door interlockingDoor interlocking shall be provided.  
  • Material of Construction (MOC) Verification Report
Sr. No.ComponentsAcceptance criteria of MOCObservationChecked by Sign/date
1.0Main bodySS 304  
2.0Side PanelSS 304  
3.0HardwareSS 304  
  • Operational and Performance Verification Report
Sr. No.OperationAcceptance criteriaObservationChecked by Sign/date
1.0Open the door from non classified area to pass the material.Classified room side door shall be locked with visual indication.  
2.0Close the door from non classified area.Audio visual indication shall be generate from the classified area. (i.e. to take out the material)  
3.0Press the push button provided at classified room side.Buzzer shall be switched off and door get unlocked.  
  • DEVIATIONS:
Sr. No.Deviation(s)Justification for acceptance criteriaImpact on Installation Operation and Performance
                      
                    
  • CHANGE CONTROL: If any shall be mentioned
  • LIST OF ANNEXURE: Annexure number shall be mentioned
  • SUMMARY AND CONCLUSION OF  QUALIFICATION:

Based on the Qualification what we have observed and whether it is suitable for use and whether it passes all the criteria as mentioned in the Qualification Protocol shall be mentioned

CERTIFICATION OF QUALIFICATION:

Qualification is satisfactory.                                       Yes/No

Hence equipment can be used for routine use.           Yes/No

Head-QA

Dosing Disc Thickness Calculation for Capsule Filling Machine


Dosing disc of Capsule Filling Machine

To control the quality and weight of capsules, we need to understanding of every aspect of a capsule filling machine dosing disc. All these revolve around calculating a proper thickness of the dosing disc.

Normally, the dosing disc thickness calculation of capsule filling machines is a difficult process that is done during the manufacturing process. In most cases, a capsule filling machine will come with different types of dosing discs depending on the type or size of capsule you intend to fill.

Now, this brings us to an integral aspect we need to consider when calculating the thickness of capsule filling machine dosing discs.

How Size of Capsules Affect Size of Dosing Disc Thickness

The modern capsule filling machines can fill a wide range of capsule sizes. This makes them suitable for a wide range of applications. It is for this reason that the manufacturer will specify the specific capsule sizes which can use with a given dosing disc thickness.

Remember, the dosing disc thickness will also affect other vital components and specifications of a capsule filling machine.

How Dosing Disc Thickness Affect Other Part Specifications of Capsule Fillers

The thickness of a capsule filling machine dosing disc influence the size of other components such as height of filling rod retainer and furthermore, a change in the height of the filling rod will affect both the density and volume of the powder.

Station12345
Depth into Dosing Disc95320.5

Clearly, we can see that the correct specifications of the dosing disc dimensions will affect the efficiency and accuracy of the capsule fill weights. Therefore, we have to perform a wide range of tests based on a number of parameters such as:

  • Type of motion – the disc is normally subjected to a rotary indexing motion.
  • How the powder moves from the hopper to the disc
  • The magnitude of centrifugal force that carries the powder to outer edges of the disc
  • Magnitude of the compression force

In the modern capsule filling setups in pharmaceutical industries, there are different test mechanisms that simulate the operation of capsule filling machines. With this, it’s easy to tell the dosing disc thickness a capsule filling process requires.

How Product Formulations Affect Dosing Disc Thickness

For different product formulations, we may required multiple dosing discs with different thickness.

But, why is this so?

A light, fluffy and a bulk heavy density product will require capsule filler dosing discs with different thickness. Therefore, we need to understand the key properties of the fill material.

Conclusion

In short, the dosing disc thickness of a capsule filling machine will determine the accuracy, precision, reliability and predictable performance of the machine. Normally, the capsule filling machine manufacturer will provide a guideline on this and remember that all the necessary calculations are done during the manufacturing process.