OBJECTIVE of PQ For Tray Dryer
To determine that the PQ For Tray Dryer perform as intended by repeatedly running the system on its intended schedules and recording all relevant information and data. Results must demonstrate that performance consistently meets pre-determined specifications under normal condition, and where appropriate the worst case situations.
TABLE OF CONTENT
| PARTICULARS | PAGE NO. |
| Title page | |
| Table of contents | |
| Objective | |
| Scope | |
| Re-Qualification Schedule | |
| Location of equipment | |
| Validation team & Responsibility | |
| Pre-approval of documents | |
| Scope of supply | |
| Brief Process Description | |
| Re-Performance Qualification Procedure | |
| Performance Verification | |
| Re-Performance Qualification Report | |
| References | |
| Result | |
| Deviation | |
| Summary | |
| Conclusion | |
| Recommendations | |
| Attachments | |
| Post approval of document |
SCOPE
To be performed after installation, modification or relocation and for the re-performance at appropriate interval or as per re-qualification planner.
Performance of the tray dryer machine shall be documented for future reference.
Assure that the mass mixer machine performance is adequate to support the process for which the system is intended.
RE-QUALIFICATION SCHEDULE
Frequency
Performance check of the machine should be re-qualified after every 5 years ±2 months.
LOCATION OF EQUIPMENT
The location of the equipment is in granulation room hormone tablet section at company.
| Name of Equipment | ID No. | Room Name | Section |
| Mass Mixer | Granulation |
VALIDATION TEAM AND RESPONSIBILITY
| Department | Responsibility |
| Production | Preparation of protocol and compilation of report. Review of protocol and report. Execution of Re-Qualification activities as per the protocol. Responsible for the compliance of Re-qualification data |
| Engineering | Review of protocol and report. To assist user/concerned department during Re- qualification activity |
| Quality Control | Review of protocol and report. Responsible for analysis of samples & evaluations of the test results. |
| Quality Assurance | Review, approval and certification of the protocol / reports. Execution & approved of re-qualification activities as per the protocol & certification after successful re-qualification of the equipment. |
PRE APPROVAL OF DOCUMENTS
Prepared by
| Designation | Name | Date | Signature |
| Executive/Officer Production |
Checked By
| Designation | Name | Date | Signature |
| Head Engineering | |||
| Head Production | |||
| Head Quality Control |
Approved by
| Designation | Name | Date | Signature |
| Head QA |
Scope Of Supply:
| Description | Specification |
| Model | GMP Model |
| External dimension:- L X W X H- (all in mm) | |
| Accessories | Door gasket |
| Exhaust damper | |
| Control system | 440 volts, three phase power supply |
Brief Process Description of PQ For Tray Dryer:
Material is charged in the mixer through nozzles or feed-hoppers mounted on the top cover of the mixer. Suppose if screw feeder is opted with mixer, then material to be load onto screw feeder and it will feed powder into mixer. Filling to be done about 70 percent of the total volume of the container. This is generally up to the level of the outer ribbon’s tip. After feeding completes then please close the top cover of the mixer and tighten the latches. Now start the machine form the control panel.
During the blending operation, the outer ribbons of the agitator interchange the material from the ends to the center while the inner ribbons transfer the material from the center to ends. Radial movement is achieved because of the rotational motion of the ribbons. The difference in the peripheral speeds of the outer and inner ribbons results in axial movement of the material along the horizontal axis of the mixer. As a result of the radial and the counter-current axial movement, homogenous blending is achieved in short time. Blending is generally performed in 15 to 20 minutes cycle time. Mixing efficiency of mass mixer depends upon particle size and its bulk density. Generally mass mixer with 95% efficiency in most of the cases. Ingredients with similar particle size and bulk densities tend to mix faster as compared to ingredients with variation in these attributes.
After mixing, material is discharged from a discharge valve located at center bottom of container. The discharge can be fitted with any of these valves like slide-gate, butterfly, flush bottom, spherical and other types depending on the application. The operation of the valves can be manual or pneumatically actuated as per requirements
- Machine rated for continuous operation.
- Easy loading & unloading storage with process uniformity.
- All contact parts of SS 316 AISI.
- All contact parts can easily be dismantled and cleaned for change of product.
- Technical Details:
- Outside controls
- Design as per stringent cGMP requirements.
- All Contact parts of AISI Stainless Steel 316 Quality
- All Non contact parts of AISI Stainless Steel 304 Quality
- Silicon Food Grade seal/ gasket
- Easy to clean all contact parts
RE-PERFORMANCE QUALIFICATION PROCEDURE
The action of repeating the qualification or reconfirming that process, product or equipment is suitable for a particular position or task.
Availability of product for operates with load to be checked.
The power supply and connected utility was checked before starting re-performance qualification.
The operating functions of control panel switches and buttons were checked before executing the activity.
PERFORMANCE VERIFICATION
Objective of this performance verification is to provide documented evidence that equipment perform as per respective and up to its operating & performance range.
Standard Operating Parameters Verification:
- Objective of this verification is to provide documented evidence that equipment perform satisfactory as per its standard operating procedure.
Cleaning check:
| Check points | Observation | Checked By (Sign & Date) |
| Check the cleanliness of the blades & bowl of the machine | ||
| Check the cleanliness of internal surface and its gasket. | ||
| Check cleanliness of the door gasket. | ||
| Check the cleanliness of the top lid & discharge area of the machine. | ||
| Check the cleanliness of the external surface of the machine. |
Safety precaution while drying of material:-
Mask and gloves should be wearing during drying of material.
Performance check of the machine/equipment:-
| Test | Acceptance Criteria | Observations | Done By Sign/Date | Checked By Sign/Date |
| Check the machine for proper placement. | Machine should be place in adequate space & there should be enough space | |||
| Check for the proper of mixing blades in the machine. | Mixing Blades should work properly | |||
| Check the uniformity of the material during mixing | Mixing blades should cover all the corners & center for proper mixing of material | |||
| Check the proper fixing of the door gasket. | Door gasket should be properly fixed & damage free. |
Test Method:
Operate the equipment as per Standard Operating Procedure SOP No. __________ for Operation & Cleaning of mass mixer machine and record the performance of the machine.
Read Also – Rapid Mixer Granulator
Testing procedure:
For performance check of the machine, take any 1 batch or products material for dry or wet mixing and check the proper mixing of the material. Uniformity of the material should meet the target level/acceptance criteria.
| Product Name | Batch Number | Observation | Checked By | Reviewed By |
Record the preventive maintenance status of the machine/equipment.
| Equipment Name | I.D. No. | Section | Detail of Preventive Maintenance | |
| Done on | Due on | |||
Acceptance Criteria:
Equipment/ Machine shall be operating as defined in the standard operating procedure, if differ then record deviation & check the performance of machine.
Uniformity of the product should meet the criteria/ limit specified in the BMR or as per the BMR.
Operation shall be smooth and there should not be any abnormal sound/ noise.
PQ For Tray Dryer REPORT:
__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
REFERENCES:
SOP No.
RESULT:
_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Checked By (Sign & date):________________
DEVIATION/CHANGE CONTROL
________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Checked By (Sign & date):________________
SUMMARY:
_______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Written By (Sign & date):________________
CONCLUSION:
_______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Written By (Sign & date):________________
RECOMMENDATIONS
_______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
Written By (Sign & date):________________
ATTACHMENTS:
| Document name | Reference No. | Checked by Sign & Date |
POST APPROVAL OF DOCUMENTS
Prepared by
| Designation | Name | Date | Signature |
| Executive/Officer Production |
Checked By
| Designation | Name | Date | Signature |
| Head Engineering | |||
| Head Production | |||
| Head Quality Control |
Approved by
| Designation | Name | Date | Signature |
| Head QA |