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1.1 Objective is to record the findings of qualification study executed as per pre-approved protocol and to show that the digital weighing balance stands qualified for routine use.
2.1 The scope of this report is limited to Digital Weighing Balance having Id No. XYZ
3.0 RESPONSIBILITIES:
Maintenance Officer/Executive: To prepare qualification protocol, 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 approve the qualification documents.
4.0 BALANCE DESCRIPTION:
Sr. No. | ID. No. | Capacity | Least count | Location | Make | Model No. | Serial No. |
1 | XYZ | Max. : 50.00 Kg Min. : 0.50 Kg | 0.01 Kg | Packing Hall | Mettler Toledo | NA | Example: ABCD |
5.0 ACCEPTANCE CRITERIA:
Qualification of the equipment should meet the acceptance criteria outlined in the following steps.
5.1 Installation Verification Report
Sr. No. | Check points | Acceptance criteria | Observations | Checked by sign/date |
1 | Check the levelling of the equipment on level indicator. | Air bubble shall be at centre position of level indicator. | ||
2 | Placing location | 1. Bench top or floor shall be steady and even surface. 2. Location shall be free from heat, vibration and moisture. |
5.2 Multimeter Calibration Verification Report
Sr. No. | Measuring Device | Acceptance Criteria | ID. No. | Calibration done On & due on | Observation | Checked by Sign/ Date |
Multimeter | It shall be calibrated for its performance. |
5.3 Calibration Status of Standard Weights
Sr. No. | Standard Weights | Acceptance criteria | Observation | Checked by sign/date |
1 | Check the calibration of standard weights. | Standard weights should be calibrated for its performance. |
5.4 Operational Verification Report
Sr. No. | Check points | Acceptance criteria | Observations | Checked by sign/date |
1 | Press ‘Φ’ button. | Balance should turn ON. | ||
2 | Press ‘T’ button. | Balance should tare (zero – setting). | ||
3 | Press ‘Φ’ button. | Balance should turn OFF. |
5.5 Utility Verification Report
Sr. No. | Utility | Acceptance criteria | Observation | Checked by sign/date |
1 | Electricity | Single phase, 230 + 10% V AC and 50 + 5% Hz |
5.6 Eccentricity Test Report
5.6.1 Procedure
Eccentricity test is carried out by placing 1/3 rd weight of maximum capacity i.e. 20.00 Kg on weighing platform at 5 different locations (four corners & center) and Values displayed by Balance against standard weight are recorded in a following table.
Location ID | Standard Weights | Observation/Weight Displayed | Checked by sign/date |
1 | 20.00 Kg | ||
2 | 20.00 Kg | ||
3 | 20.00 Kg | ||
4 | 20.00 Kg | ||
5 | 20.00 Kg |
5.7 Linearity Test Report
5.7.1 Procedure
Linearity test is carried out by placing 4 different standard weights i.e. 0.50 Kg, 15.00 Kg, 30.00 Kg and 50.00 Kg one by one on weighing platform in ascending order and by removing the placed standard weights in descending order. Values displayed by Balance against standard weights area recorded in a following table
Sr. No. | Standard Weights | Observation/Weight Displayed | Checked by sign/date |
A | Ascending order | ||
1 | 0.50 Kg | ||
2 | 15.00 Kg | ||
3 | 30.00 Kg | ||
4 | 50.00 Kg | ||
B | Descending order | ||
1 | 50.00 Kg | ||
2 | 30.00 Kg | ||
3 | 15.00 Kg | ||
4 | 0.50 Kg |
14.98 Kg to 15.02 Kg for 15.00 Kg
29.97 Kg to 30.03 Kg for 30.00 Kg
49.95 Kg to 50.05 Kg for 50.00 Kg
5.8 Repeatability Test Report
5.8.1 Procedure:
Repeatability test is carried out by placing minimum i.e. 0.50 Kg, optimum i.e. 25.00 Kg and maximum i.e. 50.00 Kg weight of capacity of balance 5 times on weighing platform and values displayed by Balance against standard weight are recorded in a following table.
Sr. No. | Standard Weights | Observation/Weight Displayed | Checked by sign/date |
1 | 0.50 Kg | ||
2 | 0.50 Kg | ||
3 | 0.50 Kg | ||
4 | 0.50 Kg | ||
5 | 0.50 Kg | ||
6 | 25.00 Kg | ||
7 | 25.00 Kg | ||
8 | 25.00 Kg | ||
9 | 25.00 Kg | ||
10 | 25.00 Kg | ||
11 | 50.00 Kg | ||
12 | 50.00 Kg | ||
13 | 50.00 Kg | ||
14 | 50.00 Kg | ||
15 | 50.00 Kg |
24.97 Kg to 25.02 Kg for 25.00 Kg
49.95 Kg to 50.05 Kg for 50.00 Kg
6.0 DEVIATION REPORT:
Sr. No. | Deviation (s) | Justification for acceptance criteria | Impact on installation, operation and performance |
7.0 CHANGE CONTROL:
8.0 LIST OF ANNEXURE:
9.0 SUMMARY AND CONCLUSION OF QUALIFICATION
10.0 CERTIFICATION OF QUALIFICATION:
Qualification is satisfactory. Yes/No
Hence Balance can be used for routine use. Yes/No
Head- Q.A.
Objective of this report is to provide documented evidence through the verification of installation, operation & performance of Tablet Friability Tester to show that the instrument installed, operated and consistently performed according to predetermine specifications.
The scope of this Report is limited to Id No. XYZ
3.0 QUALIFICATION TEAM AND RESPONSIBILITIES:
DEPARTMENT | NAME & SIGNATURE | RESPONSIBILITY |
Maintenance | To prepare qualification report. To co-ordinate the entire qualification activity. | |
Quality Assurance | To execute qualification study in co-ordination with other departments. | |
Production | To execute qualification study in co-ordination with other departments. | |
Maintenance | To review the qualification documents. | |
Head – Quality Assurance | To approve qualification protocol & report. |
4.0 INSTRUMENT DESCRIPTION:
For instrument description, should match as per re qualification protocol
5.0 ACCEPTANCE CRITERIA:
Qualification of the instrument shall be in accordance with the parameters given in Annexures – A, B, C, D, E, F, G, H, I & J of this report.
6.0 OBSERVATIONS:
Qualification shall be executed using following forms:
Annexure- A
INSTALATION VERIFICATION CHECK LIST
Sr. No | Checks to be performed | Acceptance criteria | Observation | Checked by/Date |
1 | Check for the receipt of the consignment. | It shall be received in good condition. | ||
2 | Check for any scratches on the machine body and drums. | It shall not have any scratches on machine body and drums. | ||
3 | Check for electrical connection | It shall not observed a loose or damage connection. | ||
4 | Check for levelling of the platform. | Air bubble of level indicator should be at centre. | ||
5 | Check both drums are properly locked with knob on the shaft. | Both drums should be properly locked with knob on the shaft. |
Annexure- B
CALIBRATION OF MEASURING DEVICES
Sr. No. | Measuring devices | Acceptance criteria | Observation | Checked by/Date |
1 | Vernier Calliper | It should be calibrated within calibration period. | ||
2 | Thermometer | It should be calibrated within calibration period. | ||
3 | Stopwatch | It should be calibrated within calibration period. | ||
4 | Multimeter | It should be calibrated within calibration period. |
Annexure- C
SITE INSPECTION CHECKLIST
Sr.No. | Parameter | Acceptance criteria | Observation | Checked by/ Date |
1 | Room Temperature | 15 to 30°C | ||
2 | Room Humidity | 40 to 70 % RH | ||
3 | Room environmental checks | – Away from direct sunlight. – Free from vibration. – No corrosive gases. – Free from excess dust and moisture. | ||
4 | Table space | Width :15” Length : 18” Height : 20” |
Sr.No. | Parameter | Acceptance criteria | Observation | Checked by/ Date |
5 | Point for electrical connection | Single phase of 230 V AC 50 Hz | ||
6 | Base/table level | Levelled sturdy, with no vibration. | ||
7 | Earthing | Shall be provided. |
Annexure- D
UTILITY VERIFICATION CHECKLIST
Sr.No | Parameter | Acceptance criteria | Observation | Checked by/Date |
1 | Phase Voltage: | Single Phase, 220/230 VAC, 50/60 Hz. |
Annexure- E
TECHNICAL SPECIFICATION CHECKLIST
Sr. No. | Test | Acceptance criteria | Observation | Checked by/ Date |
1 | Speed | 25 Revolutions per minute (RPM) | ||
2 | Speed Accuracy | ± 1 RPM | ||
3 | Time range | 01 Sec. to 09 Hrs.59 Min. 59 Sec. | ||
4 | Count Range | 01 to 99999 revolutions. | ||
5 | Motor | DC Stepper Motor of 3.5 KgCm Torque, 6 Volts | ||
6 | Type of the Drum | Electrolab AD Drum and Abrasion Drum. | ||
7 | Power Supply | Single Phase, 220/230 V AC, 50/60 Hz | ||
8 | Fuse Rating | T 160 mAmp – (For I/P Supply as 220/230 V AC, 50/60 Hz) | ||
9 | Dimension | 350mm (L) X 310mm | ||
10 | Weight | 12 Kg. (approx.) | ||
11 | No. of Drums | 02 Nos. | ||
12 | No. of Discharge Trays | 02 Nos. |
Annexure- F
DRUMS SPECIFICATION CHECK LIST
Sr. No. | Name | Acceptance criteria (As per USP General Chapter – 1216) | Observation | Checked by / Date | ||
1 | Drums | – One side removable. | ||||
— | — | — | Drum 1 and Drum 2 | — | ||
– | Material | Transparent synthetic polymer with polished internal surfaces. | ||||
– | Inside Radius of Curved Projection | 80.5 ± 5.0 mm. | ||||
– | Diameter of Central Hole | 10.0 ± 0.1 mm. | ||||
– | Diameter of Central Ring | 25.0 ± 0.5 mm. | ||||
– | Inside Diameter of Drum | 287.0 ± 4.0 mm. | ||||
– | Outside Diameter of Drum | 302.5 ± 4.0 mm. | ||||
– | Depth of Drum | 38.0 ± 2.0 mm. | ||||
– | Tablet Dropping Height | 156.0 ± 2.0 mm. | ||||
– | – | – | – |
Annexure- G
OPERATIONL VERIFICATION CHECKLIST
Sr. No. | Operation | Acceptance criteria | Observations | Checked by/ Date |
1 | Switch ‘ON’ the power switch. | – The drum shall initialize itself to the loading position. – The display shall now show ‘Start” | ||
2 | a) Press ‘TIME’ key to select the “TIME MODE”. | – The MODE indicator LED shall indicate the “TIME MODE”. -The display shall show the previous time values. | ||
b) Enter the desired value by using numerical keys. Press ‘ENTER’ key to register the value. | The display shall show ‘00’. | |||
c) Press ‘RUN/HALT’ key. | – The drum shall start rotating in forward direction. – The display shall show elapsed time. – When the test is over the drum shall rotate in reverse direction for discharging the tablets into the tray. – Indication of test over shall show by an audible beep. – The display shall show “END”. | |||
d) Press ‘RESET’ key. | The instrument shall initialize and will stop at the loading position. | |||
3 | a) Press ‘COUNT’ key to select the “COUNT MODE”. | – The MODE indicator LED shall indicate the “COUNT MODE”. – The display shall show the previous count values. | ||
b) Enter the desired value by using numerical keys. Press ‘ENTER’ key to register the value. | The display shall show ‘00’. | |||
c) Press ‘RUN/HALT’ key. | – The drum shall start rotating in forward direction. – The display shall show elapsed count. – When the test is over the drum shall rotate in reverse direction for discharging the tablets into the tray. – Indication of test over shall show by an audible beep. – The test over shall show “END”. | |||
d) Press ‘RESET’ key. | The instrument shall initialize and the will stop at the loading position. |
Sr.No | Test procedure | Acceptance criteria | Observation | Checked by/Date |
1 | Start the instrument. | Instrument shall run. | ||
2 | Turn main power to the instrument OFF. | The instrument shall get OFF. | ||
3 | Turn Power ON. | Instrument should not start spontaneously. | ||
4 | Start the instrument. | Instrument should resumes from the stop condition with all the parametrs found as before POWER – OFF. |
a) For regular tumbling, set the instrument at normal position, as there is no any irregular tumbling of tablets.
b) For irregular tumbling, set the instrument with 10° tilt with the bench top to prevent any irregular tumbling of tablets.
1.1 Acceptance criteria: Performance of instrument shall be found satisfactory.
1.2 For Normal Position:
Product Name:
Batch No.:
Sr. No. | Time Set in Minute | Initial weight | Final weight | Friability | Checked by/Date |
1 | |||||
2 | |||||
3 |
1.3 For 10° Tilt Position:
Product Name:
Batch No.:
Sr. No. | Time Set in Minute | Initial weight | Final weight | Friability | Checked by/Date |
1 | |||||
2 | |||||
3 |
7.0 DEVIATION REPORT:
Sr. No. | Deviation (s) | Justification for acceptance criteria | Impact on installation, operation and performance |
8.0 CHANGE CONTROL:
9.0 LIST OF ANNEXURE:
10.0 SUMMARY AND CONCLUSION OF QUALIFICATION:
11.0 CERTIFICATION OF QUALIFICATION:
Qualification is satisfactory Yes/No
Hence instrument can be used for routine use. Yes/No
Objective of this report is to check and provide documented evidence of its performance as per the predetermined acceptance criteria.
Refer working and principle of RMG https://pharmaceuticalupdates.com/2020/04/27/working-and-principle-of-rapid-mixer-granulator-rmg/
2. SCOPE:
The scope of this report is limited to equipment ID No. XYZ.
3. QUALIFICATION TEAM AND RESPONSIBILITIES:
DEPARTMENT | NAME AND SIGNATURE | RESPONSIBILITY |
Quality Assurance | To prepare performance qualification protocol and report. To co-ordinate the entire qualification activity. | |
Production | To execute qualification study in co-ordination with other departments. | |
Quality Assurance | To execute qualification study in co-ordination with other departments. | |
Maintenance | To review the qualification documents. | |
Head – Quality Assurance | To approve qualification protocol & report. |
4. EQUIPMENT DESCRIPTION:
Equipment description shall be match as per design qualification protocol.
5. ACCEPTANCE CRITERIA:
Performance Qualification of the equipment shall be in accordance with the parameters given in FORM – A of this report.
6. PROCEDURE:
Perform the qualification as per following form,
Performance of Equipment
PERFORMANCE OF EQUIPMENT
Performance of the equipment is verified by simulating the normal operation for dry mixing, granulation and milling of the ingredients. While doing the exercise consideration is given to the operational range of the equipment that is at minimum level (20% of capacity), optimum level (50% of the capacity) and maximum level (80% of the capacity). At the end of the granulation process wet mass is checked for its physical appearance.
1.0 Minimum Level: (20 % of capacity)
Product Name :
Batch No. :
Theoretical Batch Size :
Practical Batch Size :
1.1 Dry Mixing:
Uniform mixing of raw materials i.e. active and inactive materials is checked by collecting samples from 10 different locations for blend uniformity test. The result of blend uniformity test, process parameters of equipment i.e. mixer speed, chopper speed and end point ampere reading are recorded in following tables.
1.1.1 Acceptance Criteria:
Mixing of active material shall be uniform.
Blend Uniformity: 90.0 % to 110.0 %
% RSD: NMT 6.0 %
1.1.2 Process Parameters Data:
sr no. | Step | Mixer Slow | Mixer Fast | Chopper Slow | Chopper Fast | End Point Ampere | Observation entered by/date |
1 | Dry mixing cycle |
1.1.3 Blend Uniformity Test Result:
Sr. No. | Locations | Assay in % | Result entered by/date |
1 | Left – Top | ||
2 | Left – Bottom | ||
3 | Right – Top | ||
4 | Right – Bottom | ||
5 | Middle – Top | ||
6 | Middle – Bottom | ||
7 | Front – Top | ||
8 | Front – Bottom | ||
9 | Back – Top | ||
10 | Back – Bottom | ||
Minimum | |||
Maximum | |||
Average | |||
% RSD |
1.2 Wet Mixing (Binder Addition):
After addition of binder solution, checked the wet mass, process parameters of equipment i.e. binder solution temperature, mixer speed, chopper speed and end point ampere reading. The observations are recorded in following tables.
1.2.1 Acceptance Criteria: Wet mass shall be coherent.
1.2.2 Process Parameters Data:
Binder solution temperature:
Sr No. | Steps | Mixer Slow | Mixer Fast | Chopper Slow | Chopper Fast | End Point Ampere | Observation entered by/date |
1 | During binder solution addition. | ||||||
2 | After completion of binder solution addition. | ||||||
3 | Additional purified water, if added. Quantity : |
1.2.3 Physical Appearance of Wet Mass:
Sr.No. | Test | Observation | Checked by/date |
1 | Physical appearance |
The wet mass after granulation is passed though the cone mill and the same is checked visually for its size and uniformity.
1.3.1 Acceptance Criteria: Wet granules size shall be uniform.
1.3.2 Physical Appearance of Wet Mass:
Sieve details:
Sr.No. | Test | Observation | Checked by/date |
1 | Visually check wet granules for its size. |
Repeat the above mentioned process for optimum level (50% of the capacity) and maximum level (80% of the capacity).
7. Deviation Report:
Any deviation reported during process with respect to acceptance criteria shall be justified and it’s it’s impact on equipment qualification shall be evaluated.
8. CHANGE CONTROL:
Change control number shall be mentioned.
9. List of Annexures:
Annexures shall be attached to the PQ Report.
10. Summary and Conclusion of Performance Qualification:
The results and final conclusion shall be mentioned that the equipment performance is found satisfactory at load condition and analytical and physical parameters performed at different capacities are found satisfactory.
11. Certification of Performance Qualification:
Performance Qualification is satisfactory Yes/No
Hence equipment can be used for routine use Yes/No.
Certification shall be taken from Quality Assurance before use.
1.0 | Objective : |
To lay down a procedure for Training and Qualification of Quality Control Analyst. | |
2.0 | Scope : |
The scope of this document is to provide the procedure for Training and Qualification of Quality Control Analyst. | |
3.0 | Responsibility : |
3.1 | Quality Control Personnel : |
3.1.1 | To undergo Training and Qualification. |
3.2 | Quality Control Head / Designee : |
3.2.1 | To review and monitor the procedure for Training and Qualification of Quality Control Personnel. |
5.0 | Procedure : |
5.1 | Training shall be conducted by Manager / Designee for relevant core/ as per SOP, “Procedure for Training of Plant Personnel. |
5.2 | Incase of SOP training the trainee shall be considered as ‘trained’ if analyst gets the qualifying score (> 80%) and should be evaluated through assessment questionnaire as per SOP, “Procedure for Training of Plant Personnel otherwise retraining shall be considered. |
5.3 | Upon completion of training program, the new joinee shall undergo qualification process for all tests / techniques relevant to that area in which analyst is supposed to work. |
5.4 | Based on the category to which the analyst belongs as per the discussion with the Head of Department, the tests in which the analyst shall be trained and qualified depending on the job responsibilities shall be identified. |
5.5 | Non Complex Analytical Techniques are those for which a practical demonstration shall be provided by the trainer as per Annex – 1. As part of demonstration of these techniques, the Manager / Designee shall explain the test procedure to the analyst who is under training. |
5.6 | Trainee shall enter the key learning points in the Analyst Qualification report. |
5.7 | The details of the analytical techniques in which the analyst is trained and qualified shall be recorded in the current version of the “Analyst Qualification Record”, |
5.8 | For complex analytical techniques the analyst shall be trained by Manager / Designee and key points of the analytical techniques shall be recorded by the trainer in “Analyst Qualification Record” during training. |
5.9 | The analyst shall perform the test as per STP / Specification / GTP and qualification under the supervision of trainer and the qualification shall be verified as per the acceptance criteria. |
5.10 | The trainer shall use the checklist provided in Annex – 3 to verify that the analyst undergoing qualification performs correct unit operations. |
5.11 | Manager / Designee shall generate the Analyst Qualification Number (A.Q. No.) for each analyst as per procedure given below and this number shall be referred in analyst qualification raw data. |
5.11.1 | AQXXYYY, Where AQ stands for Analyst qualification, XX denotes the last two digits of calendar year (20 for 2020) & YYY denotes the serial number. |
5.11.2 | e.g. The Analyst qualification number for the first Analyst qualified in the year 2020 will be AQ20001 |
5.12 | For each analytical technique, the details such as “Name of Analytical Technique”, “Product” / “Material Name”, “Batch” / “Lot Number”, “A. R. Number” of the previous analysis shall be recorded in the “Analyst Qualification Register”. |
5.13 | The details of analysis shall be recorded in the “Calculation Sheets” / “Test Data Sheets”. In case the qualification is performed on routine samples, the A.R. Number of the sample being analyzed shall also be recorded in the “Analyst Qualification Register” as a reference. |
5.14 | The trainer shall review analytical results and consider the analyst as qualified, if the result of the test performed is complying with the acceptance criteria. |
5.15 | Head of Department or his designee shall review the data of technique for which the analyst is under qualification and provide comments as “Qualified” or “Not Qualified” in the “Analyst Qualification Register”. |
5.16 | At the beginning of every calendar year Manager / Designee shall prepare a schedule for re-training of relevant analytical techniques for each of the qualified personnel in the section in “Analytical technique Schedule”. |
5.17 | The trainee shall be considered as trained only after the trainee qualifies as per the questionnaire. |
5.18 | If the Analyst is having more than 2 years and above experience and have performed the similar analysis in previous organisation then depending upon the evaluation of previous experience and his expertise in the respective analytical technique, complex analytical technique need not be performed. In this case Analyst can directly put on the job by giving respective analysis of ongoing samples in presence of trained analyst and if the result meets the acceptance criteria then the analyst can be considered as Qualified Analyst. |
5.19 | Requalification of the Analyst shall be carried out if the analyst is absent for more than 60 working days. |
6.0 Distribution :
This SOP (Controlled Copy) shall be distributed to Quality Control Department.
7.0 Annexures :
Annex-1 Non Complex Analytical Techniques for Qualification of Analyst
Annex-2 Complex Analytical Techniques for Qualification of Analyst
Annex-3 Checklist for Analyst Qualification.
8.0 Abbreviation :
Nil
9.0 Reference(s) :
Nil
10.0 SOP Revision History Record :
Revision No. | Details for Revision(s) with Change Control No. | Effective Date (Sign. / Date) |
Annex-1
Non Complex Analytical Techniques for Qualification of Analyst
Sr. No. | Analytical Technique |
1 | Description / Characteristics |
2 | Solubility of Solution |
3 | Appearance of Solution / Colour and Clarity of Solution |
4 | pH of Solution |
5 | Loss on Drying |
6 | Sulphated Ash |
7 | Residue on Ignition / Loss on Ignition |
8 | Heavy Metals |
9 | Limit tests such as Chloride, Sulphate, Nitrate, Lead, and Arsenic. |
10 | Bulk Density (Tapped / Untapped) |
11 | Distillation range |
12 | Melting Point |
13 | Sieve Analysis |
14 | Disintegration test |
15 | Friability |
16 | Thin Layer Chromatography |
17 | Preparation and Standardization of Volumetric solutions. |
18 | Determination of conductivity |
19 | Identification (FTIR, UV) |
Annexure-3 Checklist for Analyst Qualification | |
Name of the Analyst | : |
Product / Material/ Batch / Lot Number/ A. R.No. | : |
Test being performed | : |
Name of the Supervisor & Date | : |
Sr. No. | Checklist | Observation (Yes / No / NA) |
1 | Is the analyst using the correct analytical method for performing the analysis? | |
2 | Is the analyst using calibrated equipment / instrument for performing the analysis? | |
3 | Is the analyst using the correct working standard / reference standard? | |
4 | Is there evidence that the solutions/ reagents used during the analysis were within their validity period? | |
5 | Is it evident that the analyst is taking all the safety precautions? | |
6 | Is the analyst using the analytical balance correctly? | |
7 | Is the analyst using clean weighing accessories, like spatula, Butter paper, etc.? | |
8 | Is the solution prepared by the analyst labeled appropriately? | |
9 | Is the analyst using the correct glassware / reagents / chemicals / as mentioned in the analytical method? | |
10 | Is the analyst making concurrent documentation of the activity being performed? | |
11 | Are samples/ solutions stored appropriately during the analysis? |
Specific Observations for the Analytical Technique | |
Supervisor (Sign) & date:
ALCOA and CCEA (complete, consistent, Enduring and Available)
CCEA (++++ Complete, Consistent, Enduring and Available)
FBD is used for drying of different pharmaceutical materials or products and it can easily achieve specific moisture content in granules and powders.
FBD is able to remove excess moisture from different materials and its working principle is so precise and focused on drying the materials without changing their physical attributes.
Here are the main functions as to why you should perform solid drying.
In fluidization process, hot air is introduced at high pressure through a perforated bed of moist solid particulate. The wet solids are lifted from the bottom and suspended in a stream of air (fluidized state). As the hot air passes between the particles it takes the excess moisture from the particles thus drying the particles.
Heat transfer is accomplished by direct contact between the wet solid and hot gases.
Step 1: Fluidized bed dryer loading :
Loading of materials involves adding a fresh batch of wet granules into the product chamber through negative pressure feeding, materials can be sucked from the high shear mixer chamber through a feeding tube.
Step 2: Air inlet (intake) :
Switching the blower unit on is done from the control panel. Once the blower is operational, the air is drawn continuously from the Air Handling unit and into the tower through the lower plenum.
Step 3: Fluidization :
Inlet air is blown up through the static power bed as the velocity of the air increases so does the space between powder particles until the particles become suspended in a bed the fluidization process is through to occur in five stages including smooth fluidization, bubbling fluidization, turbulent fluidization and first fluidization.
Step 4: Drying:
The drying process takes place in three stages until the end point is reached (At the end point the solid particles moisture level is equal or less than 1%)
Step 5: Pre heating:
Wet particles are suspended in hot and dry air stream. Moisture on the particles surface evaporates as heat flows through the body (conventional heating) the rate of drying slowly increases as the particles absorb more heat.
The moisture lost during preheating is still small but the temperature of the bed rises steadily.
Step 6: Filter bag shaking:
The blower continuously draws and excels air from Fluidized bed dryer. The airstream may contain very small particles called fines. The filter bags capture the fines in their pores but this cause the formation of a dust layer that clogs the filter bags causing a pressure drop.
Mechanical shaking is the best way to remove the dust layer and it is done by the pneumatic cylinder at the set intervals and seems we have two filtering chamber the shaking is alternated between the two.
Refer Fluid Bed Dryer Filter Bag
Step 7: Discharging of dried material:
Discharging refers to the removal of dried materials from fluidized bed dryer. It can be done manually by unlocking and wheeling the product container on its trolley to the next process equipment.
Alternatively, vacuum conveying can be carried out by connecting the product container with a tube and creating negative pressure for suction using a vacuum transfer system. After drying, the next process is milling.
You cannot use the fluid bed dryer for reducing excess moisture in organic solvents or substances containing organic solvents.
This is because the organic solvents usually dissolve in the products thus making it very difficult to dry.
Fluid bed dryers use high levels of hot gas and air thus making it difficult to dry toxic or flammable materials.
This may place the lives of the people operating the machine or around the machine in great danger.
When we use the fluid bed dryer there are high chances of electrostatic build up during the drying process.
It is a phenomenon that will happen especially when we are drying organic particles.
We should, therefore, go for the fluid bed dryers with electrical earthing elements to avoid this problem.
The main principle of drying using the fluid bed dryer is the movement of particles as it takes away excess moisture.
We will, therefore, experience a lot of problems when it comes to drying sticky materials as they don’t move freely.
For the contact parts of FBD we should use AISI 316 and non-contact parts AISI 304.
The main quality standard and certification are
Below given are the details of causes and solutions of defects in tablet Manufacturing.
The defects are capping, Lamination, Picking, Sticking, Cracking and Chipping.
1.1 To lay down a procedure for operation of Friabilator, Make: Electro lab
2.0 RESPONSIBILITY
2.1 Technical Assistant / Production Executive / IPQA Executive – To Perform as per SOP.
2.2 Production / IPQA In-charge – To ensure the compliance.
3.0 PROCEDURE
3.1 OPERATION :
3.1.1 Switch ON the mains.
3.1.2 Press the START/STOP switch on the rear right hand side of the instrument base, then the drum will initialize itself to the loading position and simultaneously display shows START.
3.1.3 Mode setting – TIME, COUNT key are toggle keys to set in Timer mode or Count mode of operation. 3.1.4 Set the Time in the following procedure:
3.1.4.1 Press “RESET” key.
3.1.4.2 Press “TIME” key.
3.1.4.3 Enter the required duration of time by pressing the numeric digits.
3.1.4.4 Press “ENTER” key to set the time.
3.1.5 Set the Count in the following procedure:
3.1.5.1 Press “RESET” key.
3.1.5.2 Press “COUNT” key.
3.1.5.3 Enter the desired number of rotations by pressing the numeric digits.
3.1.5.4 Press “ENTER” key to set the count.
3.1.5.5 After completing the parameter settings, slide the tablets gently into the drum from the side slit provided on the drum.
3.1.5.6 Select the Time mode or Revolution count mode as desired by pressing the “TIME / COUNT” key respectively.
PRECAUTIONS:
3.1.6 Weigh the quantity of tablets to be tested as per the BPRR specification from LHS and RHS of compression machine.
3.1.7 Record the weights of tablets in BPRR if provided and load the tablets to friabilator drum.
3.1.8 Press “RUN / HALT” key to start the test. “RUN / HALT” is a toggle key to start and stop the test.
3.1.9 Drums rotate in forward direction as per the set (TIME/COUNT) mode.
3.1.10 Completion of test is indicated by an audible beep and the display shows “END”.
3.1.11 When the test is over, the drums rotate in the reverse direction for discharging the tablets into the trays. After discharge of tablets drums initialize to loading position and the display shows “START” indicating the instrument is ready for next test.
3.1.12 Slide out the tray and take out the samples for weighing.
3.1.13 Dedust the tablets using nylon brush, weigh and record in BPRR.
3.1.14 Calculate and record the friability as per BPRR.
Note:
3.2 CLEANING :
3.2.1 Clean the Friabilator frequently by following procedure.
3.2.2 Switch off the power supply to the instrument before cleaning the equipment.
3.2.3 Remove the trays in the tray holders.
3.2.4 Remove the drums from the shaft by pressing the button on the knob and pull out the knob.
3.2.5 Clean the drums, trays and knob with lint free cloth dipped purified water and wipe with dry lint free cloth.
3.2.6 Wipe off the exterior of the equipment with lint free wet cloth.
3.2.7 Reassemble the drums and tray in the reverse order of dismantling.
3.2.8 Update the status label as CLEANED.
3.2.9 Switch off the mains of the tablet friability apparatus after the days operation.
Frequency : After every batch irrespective of product, or Weekly (if machine is in
operation), or Monthly (if machine is idle) which ever is the earlier and as and when required.
4.0 ABBREVIATIONS
Nil
5.0 REFERENCES
Nil
6.0 ANNEXURES
Nil