OBJECTIVE of PQ for Blender
To determine that the PQ for Blender 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 blender machine shall be documented for future reference.
Assure that the blender 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-qualify after every 5 years ±2 months
LOCATION OF EQUIPMENT
The location of the equipment is in granulation room.
| Name of Equipment | ID No. | Room Name | Section |
| blender | Granulation |
VALIDATION TEAM AND RESPONSIBILITY
| Department | Responsibility |
| Production | v Preparation of protocol and compilation of report. v Review of protocol and report. v Execution of Re-Qualification activities as per the protocol. v Responsible for the compliance of Re-qualification data |
| Engineering | v Review of protocol and report. v To assist user/concerned department during Re- qualification activity |
| Quality Control | v Review of protocol and report. v Responsible for analysis of samples & evaluations of the test results. |
| Quality Assurance | v Review, approval and certification of the protocol / reports. v 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:- | |
| Accessories | Lid/cover both end |
| Gear box cover | |
| Control system | 440 volts, three phase power supply |
Brief Process Description:
The Blender is an efficient and versatile blending machine for mixing and lubrication process of dry granules equally. It can be used for pharmaceutical, food, chemical and cosmetic products etc. double cone Blender consists of cone shaped body, rectangular central portion and top and bottom polygonal frustum. It is provided with baffles for fast and efficient mixing, charging port and outlet with butterfly valve. It is very useful machinery for pharmaceutical industry where in gentle blending of dry granules or powder is to be done. Other important feature of this machine is easy to clean in place. The bin charging system can also be incorporated in it which is a dust free closed system for charging and discharging of powders or granules. The powder consumption is comparatively lower than the other similar type of blender.
- Two third of the volume of the cone blender is filled to ensure proper mixing.
- Machine rated for continuous operation
- Higher output 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 mobility
- Easy to clean all contact parts
Read this also :- URS of Blender
PQ for Blender 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 operate with load was checked.
- The power supply and connected utility was checked before starting performance qualification.
- The operating functions of control panel switches and buttons were checked.
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 blender cone. | ||
| Check the cleanliness of the cone lid and its gasket. | ||
| Check cleanliness of the electrical panel inside and outside. | ||
| Check the cleanliness of gasket and clamp. | ||
| Check the cleanliness of External body of the blender. |
Safety precaution while blending process of material:-
Mask and gloves should be wearing during blending process.
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 the machine for abnormal vibration during blending of material. | Machine vibration should not be abnormal. | |||
| Check the proper locking of lid with gasket to avoid spillage. | Lid should be properly locked with gasket & locking mechanism & there should be no leakages or spillage. | |||
| Check the smooth movement of the blender. | Loaded blender should be move smoothly. | |||
| Check the RPM of the machine. | Machine RPM should be as per set RPM. |
Test Method:
Operate the equipment as per Standard Operating Procedure SOP no. for Operation & Cleaning of Double cone blender machine and record the performance of the machine.
Testing procedure:
For performance check of the blender machine, take any once batch or products material and mix the material using blender on RPM as per the BMR
| 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.
- RPM of the machine to be set as per the BMR for the product & mixing should be proper. Results after mixing should meet the active material claim.
- Operation shall be smooth and there should not be any abnormal sound/ noise.
RE-PERFORMANCE QUALIFICATION REPORT for PQ for Blender:
__________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
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 PQ for Blender 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 |