Change Control Related Questions and Answers

Below given are some questions and answers related to change control in Pharmaceutical so pl go throug it and provide your comments

Handling of Market complaints

  1. OBJECTIVE

To lay down a procedure for receipt, investigation, review and response of market complaints

2.         RESPONSIBILITY

  • In charge / Designee – Quality Assurance shall be responsible
  • For handling market complaints
  • Maintaining relevant documents and market complaint register.
  • Keeping the procedure current and applicable
  • In charge– Quality Control and In charge – Production
  • Assist in investigation of the market complaint
  • In charge – Marketing.
  • Responsible to provide all relevant information on market complaint.
  • Head – QA –Ensure implementation /compliance of this procedure.
  • Qualified Person of respective contract Mfg- For contract Mfg Products-To provide all relevant information on market complaint.

3.         PROCEDURE

  • Any complaint received for the marketed product from the end user, customer, retailer, distributor or field staff or marketing manager regarding the purity, efficacy, labeling  defect, or any other such complaint shall be considered as a Market Complaint.
  • Any communication in written or verbal, received directly or through respective country    manager /representative shall be considered as a complaint.
  • Wherever possible efforts shall be taken to get the complaint sample. If complaint sample not available, investigation shall be carried out with the control sample based on the nature of complaint. After receiving of the sample the same shall be kept as per storage conditions mentioned on the sample till investigation of complaint.
  • Country Manager/representative shall send a copy of correspondence received from the complainant and a complaint sample (if available) to In charge – QA/designee.     
  • Control sample shall be taken from the control sample section by sending communication.
  • On receipt of complaint, In charge – QA/designee shall document the following details in  the Market complaint register.
  • Complaint number
  • Date of receipt
  • Product Name & Strength
  • Batch Number
  • Date of manufacture
  • Date of expiry
  • Name, address and telephone number of the complainant
  • Nature of the complaint.
  •  Replied on
  • Corrective and preventive action
  • Disposition date
  • After receiving the complaint sample,(If available) In charge – QA/designee shall document the details in complaint sample register.
  • Complaint receiving date.
  • Complaint number.
  • Complaint sample receiving date.
  • Product Name.
  • Batch Number.
  • Complaint received from.
  • Number of samples received.
  • Investigation for physical examination  / Analysis.
  • Investigation completed on.
  • The market complaint received shall be assigned with an alphanumeric numbering system market  wise:
C   ZXXYY

C          –          Complaint

Z          –           U/E/O/B

U for USA Market. & E for Europe Market. & O for Other Market. & B for Brazil market.

XX       –           Market complaint number

YY       –           Year of the market complaint

  Example: First complaint received from US market in 2020 shall be numbered as follows:

CU0120
  • If any complaint sample is received, the same shall be labeled with the complaint number.
  • Each complaint shall be entered into the “Market Complaint Information form”
  •  A personnel shall send a field alert report, where required, within two working days to    concern regulatory authority as per SOP
  • Note:  Complaint received, for the product not marketed, from any contract manufacturer or from our warehouse or distribution center   shall also be investigated and records to be   maintained. The numbering system for the complaints shall be five characters and mentioned below:
CXXYY

Where C – Complaint, XX   is the serial number  and YY is the year of the complaint.

  • Complaint shall be classified as follows to facilitate the investigation
  • Packaging complaints
  • Quality complaints
  • Medical complaints
  • Packaging and Quality complaints shall be jointly investigated by QA In – Charge, Manager – QC, Formulation Research Development In-Charge and Production In- Charge.
  • The following shall be considered while investigating the Packaging / Quality complaints:
    • Inspection of the defective product received.
    • Analysis of the defected product if required.
    • Review of the batch processing and packaging records.
    • Physical examination of the reference sample.
    • Analysis of the reference sample.
  • Before starting of investigation of market complaint, complaint information form to be filled as per available information, during investigation all supportive documents which were reviewed and  collection of documents (If required) and other information to be filled as per the market complaint checklist at the end of investigation the same should be retained along with investigation report.
  • Wherever required Medical complaints shall be investigated in co-ordination with medical doctor or equivalent or pharmacovigilance coordinator.
  • Investigation shall be extended to other batches, which were manufactured with same Raw Material and primary packaging material during same time period and likely to be affected.
  • A manager or designee in co-ordination with the concerned departmental head shall arrange for review of the batch documents for any abnormalities, deviations, and incidents. Where necessary the equipment /instrument usage logs, personnel training records, stability data, trends etc.shall be reviewed.
  • QA Incharge shall arrange for the examination of complaint sample, where available,  along with the reserve sample of the complaint batch as necessary.
  • Check if similar complaints have been received earlier, during the last one year. If the complaint is repeated, check and ensure whether the preventive actions proposed have been implemented and are effective.
  • Wherever applicable the Investigation shall be carried out as per SOP failure investigation and various investigation tools shall be used to find out the probable root cause and  reports shall be summarized. After completion of the investigation, incharge Quality Assurance shall discuss the findings with Head – Quality Assurance.

Refer Investigation tools used in pharmaceuticals https://pharmaceuticalupdates.com/2020/02/10/investigation-tools-used-in-pharmaceuticals/

  • The Quality Assurance incharge along with the concerned departments In-charge and Head- QA shall propose the necessary corrective and preventive actions to avoid the reoccurrence of the complaint.

In case of any intimation of market complaint received from contract giver a detail investigation shall be carried out and shall be forwarded to Qualified Person or equivalent designee of contract giver for necessary action.

  • If the investigation report concludes that the product will put the public at risk such    complaints shall be referred to recall committee for taking recall decision        .
  • The complaint investigation report shall be written and filed in Quality Assurance department.
  • Based on the complaint investigation report, Quality Assurance shall communicate the appropriate conclusions stating whether the complaint is substantiated or not to the concerned complainants or to the  appropriate agency.

The investigation report shall be sent to the complainant with in 30 days from the   date of the receipt of the complaint unless otherwise justified.

  • Incase where Head – Quality Assurance finds that investigation is not necessary such written records shall be maintained including the reason for not conducting the  investigation.
  • After completion of the corrective action and preventive actions, complaint shall be closed.
  • All the documents related to the Product complaints shall be retained for one year after   the     expiration date / one year after the date of receipt of the complaint whichever is longer.
  • Based on the nature of complaint, trend shall be prepared once in a year.
  • Quarterly summaries shall be prepared and forwarded to Director   Pharma and Head– Quality Assurance for information.
  • In case of any complaint which is already investigated and closed from the customer end, the same shall also be investigated at our site once again along with customer report.
  • Handling of Market Complaint Samples
  • The remaining complaint samples shall be maintained by incharge / designee QA at the storage conditions specified for the drug product for a period of one year after the expiry date of the drug product or one year after the date on which complaint was received which ever is longer.
  • On completion of the specified retention period the samples shall be destroyed and record of it shall be maintained.

4.         ABBREVIATIONS

4.1       QA       – Quality Assurance

4.2       QC       – Quality Control

5.         REFERENCES

5.1       Product Recall.

5.2       Failure Investigation.

5.3        Field Alert

5.4       Sampling, storage and Destruction of Reference/Control samples 

            of Raw materials and Drug Products

6.          ANNEXURES

6.1             Market Complaint Information Form.

6.2             Investigation form.

6.3            Requisition for  reference samples / Complaint samples

6.4       Market Complaint check list.      

Performance Qualification of Colour Camera System for Blister Packing Machine

Function of camera in Blister Packing Machine :

The Color Camera System is to be attached on to the blister packing machine.  It is designed to detect and reject the defective blisters during blistering of the product.

It can inspect tablets or capsules (hard or soft gelatin) blistered in following types of material of construction with maximum blister dimension of 200 x 160 mm.

PVC or PVDC (Clear, Color or Opaque)

ALU/ALU

It can detect and reject the blisters having following defects:-

Broken tablets, damaged capsules

Partially or fully empty blister.

Blisters containing products of different size or shape.

Product having spots (which is not its specification)

Blisters containing foreign particles.

PERFORMANCE QUALIFICATION REPORT :

Performance is checked by performing the following tests.

Performed all the tests at 3 different speeds of blister packing machine and for the entire track and the details of the product used for performance qualification and observations shall be recorded in the following tables.

Minimum Speed, Optimum Speed and Maximum speed of Machine :

Product Name:                                                        Batch No.:        

Batch Size:                                                               Pack Size:

Sr. No.TestTest Procedure  Acceptance Criteria
1Verification of rejection of blister without product (Completely empty)Create the blisters without product and run the blister packing machine.
Check whether empty blisters are rejected by system or not. Repeat for 3 times.
All empty blisters shall be rejected by the system.
2Verification of rejection of one empty pocket.Create blisters with missing product between two good blisters. That is one pocket should not have product.
Check whether the same is rejected by system.
Repeat for 3 times at 3 different positions for all the blisters in the track.
All blisters with missing product should be rejected by the system.
3Verification of rejection of spots discoloration.Create the spot on product with pen/marker.
Place the product with spot facing towards camera in the blister and run the blister packing Machine.
Check whether the product is rejected or not by system. Repeat for 3 times at 3 different positions for all the blisters in the track.
All blisters with products having spots should be rejected by the system.
4Verification of rejection for broken units.Insert broken product in a blister and run the blister packing machine.
Check whether the product is rejected or not by system. Repeat for 3 times as approximately 10%, 25% and 50% breakage of product.% of broken tablet shall be done on weight basis. Take the weight of intact tablet and break the edges of the tablets to achieve required % breakage.
All blisters with broken product should be rejected by the system.
Sr. No.TestTest Procedure  Acceptance Criteria
5Verification of rejection of object different colour.            Create the object of different colour of same product with methylene blue and run the blister packing machine.
Check whether the product is rejected by system. Repeat for 3 times by placing the different product at 3 different positions in the blister.
All blisters with different colour product should be rejected by the system.
6Verification of the effect of the changes in the tolerance value for the area and spot.  Set the tolerance value at 5 and check for spot on the tablet and 10% broken tablets.
Check whether the product is rejected by system. Perform the test at different tolerance. i.e. 10 & 20.
All blisters with defective product should be rejected by the system.
7Verification of the count i.e. no of packs between the camera and the punching tool for the rejection of the defected blister.Enter the count for rejection between the camera and punching tool correctly.  Defected blister shall get rejected after punching.    
8Verification of the count for the rejected blisters during the packing.            Ensure the count for each type of rejection is zero.
Run the machine with the different type of defects and collect the blisters after rejection separately as per the type of defect.
Check whether the count shown in the screen matches with the collected rejection of the blister as per the type of defect or not.  
The count for the rejected blisters of each type should match with the collected blisters after rejection.

Procedure for cleaning of Octagonal Blender

  1. OBJECTIVE :
  • To describe the procedure for cleaning of Octagonal Blender

2.0       RESPONSIBILITY:

2.1     Technical Assistant –Production shall be responsible to perform the cleaning of Octagonal Blender.

2.2 Executive-Production shall be responsible to ensure the cleaning of Octagonal Blender as per SOP

3.0         PROCEDURE:

   3.1    TYPE “A” CLEANING  (Batch to Batch Cleaning):

  • Ensure that status label shall be  updated as “TO BE CLEANED”.
  • Ensure that mains to the machine are switched off before cleaning.
  • Remove labels, materials and containers of previous batch from the blending area.
  • Remove all the adhered material from the outer surface of the octagonal blender  and charging bin using vacuum cleaner.
  • Record the cleaning details in the equipment log sheet. 
  • Line clearance shall be taken from QA department before starting the operation.

  FREQUENCY: After every batch of same product.

3.2     TYPE“C”CLEANING ( Product to Product Cleaning)

  • Ensure that the status label shall be updated as “TO BE CLEANED”.
  • Switch off the mains of the octagonal blender shall be switched off and cover all the electrical points with polythene cover.
  • Remove any material; labels and containers of previous product from the octagonal blender area.
  • Dismantle the rectangular window lid by unclamping ring nuts using rod  spanner.
  • Ensure that status label shall be updated as “TO BE CLEANED.”
  • Switch off the mains of the octagonal Blender and cover all the electrical points with polythene cover.
  • Remove any material, labels and containers of previous product from the octagonal blender area.
  • Dismantle the rectangular window lid by unclamping ring nuts using rod spanner.
  • Remove the gasket.
  • Dismantle the baffle, charging cone, and butterfly valve from the blender by unbolting the nuts.
  • Transfer the dismantled parts and charging bin, clamp and jacking trolley to the   washing area using SS trolley after affixing “TO BE CLEANED” label.

    CLEANING OF MAIN BODY AND AREA

  • Any adhering material from the octagonal blender shall be removed using vacuum cleaner.
  • Blender inner and outer surface shall be cleaned with about 100 L of raw water using nylon scrubber until no adherent material is observed.
  • Rinse the inner and outer surface of the blender with about 70 L of raw water. Finally octagonal blender shall be rinsed with about 60 L of purified water.
  • Polythene bag fixed to the electrical points shall be removed and wiped with dry lint free cloth.
  • The blender shall be wiped with 70% IPA by using lint free cloth.
  • Walls, ceiling, doors and glass shall be wiped with lint free cloth. Mop the area with disinfectant solution.

CLEANING OF RECTANGULAR LID, CHARGING CONE, BUTTERFLY VALVE, SS BIN, AND BAFFLE:

  • Wash the dismantled parts and charging SS bin, clamp and jacking trolley with  about 100L of raw water by using nylon scrubber until no adherent material is  observed.
  • Rinse with about 70 L of raw water.
  •  Finally rinse the parts with about 50L of purified water and dry the parts in the IR  drier, record the drying details in the IR logbook.
  • Wipe the jacking trolley with 70 % IPA.
  •  Transfer the cleaned parts to cleaned blending area after affixing CLEANED label.
  • Assemble the dismantled parts in the reverse order of dismantling and close all the open parts using shrink film.
  • The status label shall be updated  as CLEANED.

 NOTE: Care is to be taken so that no water enters in to the control panel and gearbox assembly.

FREQUENCY: After every batches (of different product), or after every 6 days (if continuous production of same product)

monthly (if machine is idle) whichever is earlier and as and when    required.

4.0       ABBREVATIONS

4.1        SS        -Stainless Steel.

4.2        QA      -Quality Assurance.

4.3        QC      -Quality Control

4.4        IPA     -Isopropyl Alcohol

5.0       REFERENCES

Nil

6.0             ANNEXURES

Nil    

7.0       Distribution

This SOP (Controlled Copy & Display copy) shall be distributed to Manufacturing  department.

8.0       SOP Revision History record

Revision No.Details for Revision(s) with Change Control No.Effective Date (Sign. / Date)

Procedure for indent, receipt, usage and specifications of Fluid Bed Drier Filter Bag

1.         OBJECTIVE

 1.1      To lay down a procedure for indent, receipt, usage and specifications of Fluid Bed Drier Filter Bag.

2.         RESPONSIBILITY

  • Technical assistant – To follow the SOP.
  • Executive – To comply the SOP.
  • PROCEDURE

What is Fluid Bed Drier :

Fluidized bed dryer (also called fluid bed dryer) is a kind of equipment used extensively in the pharmaceutical industries to reduce the moisture content of pharmaceutical powder and granules. The equipment works on a principle of fluidization of the feed materials.

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). Heat transfer is accomplished by direct contact between the wet solid and hot gases.

3.1       INDENT:

3.1.1    Production personnel to indent the new FBD filter bag as and when required.

3.1.2    The indent is raised as per the specification of the particular FBD bag and with product name.

3.2 RECEIPT:

3.2.1 The engineering stores personnel shall receive the FBD filter bag along with the party’s COA, regarding filter cloth used in FBD bag manufacturing and inform the production personnel about the receipt.

3.2.2 After receiving the information about the receipt from engineering stores, the production personnel shall check the party’s COA as per the specification.

3.2.3 The production personnel shall record the receipt and initiate for joint inspection of the FBD filter bag visually for absence of holes, foreign particles, fibres, stitching quality, bag diameter, finger diameter, finger length and number of fingers by the production personnel and QA personnel. 

3.2.4 Record the receipt and inspection of FBD filter bag.

3.2.5 After inspection, transfer the FBD filter bag to the washing area for washing, followed by drying.

3.2.6 After drying store the cleaned FBD filter bag in a polythene bag and close the polythene bag after affixing CLEANED label and kept in HDPE container labelled with the corresponding product name.

3.2.7 Store the HDPE containers, which contained cleaned FBD filter bag in change parts room.

Note: Do not store more than one FBD filter bag in a polythene bag.

3.3 USAGE:

3.3.1 Record the details of FBD filter bag usage, integrity checking (visually), cleaning and discarded dates.

NOTE:

1. Check the integrity of the FBD filter bag before and after use.

2. Incase of any damage to the FBD filter bag, discard that FBD filter         bag.

3.4 SPECIFICATIONS:

Specification is given for 150 kg Capacity with Alliance Company and different capacities of FBD Filter bags is available with different companies and their specification can vary accordingly. The below details are given for reference purpose.

4.0 ABBREVATIONS

4.1        FBD     :           Fluid Bed Drier

4.2        QC       :           Quality Control

4.3        HDPE  :           High Density Poly Ethylene

5.0 REFERENCES

5.1        Destruction procedure for tableting tools, processing aids and change parts.

6.0 ANNEXURES

6.1        Receipt and Inspection Report of FBD Filter Bags.

6.2        FBD Filter Bag Usage Record.

7.0       Distribution

This SOP (Controlled Copy & Display copy) shall be distributed to Manufacturing  department.

8.0       SOP Revision History record

Revision No.Details for Revision(s) with Change Control No.Effective Date (Sign. / Date)

Cleaning Procedure for Multi mill

1.0       OBJECTIVE

1.1       To lay down a cleaning procedure for Multimill.

2.0       RESPONSIBILITY

  • Technical Assistant – To follow the SOP.
  • Executive – To comply the SOP.

3.0         PROCEDURE:

  3.1     TYPE “A” CLEANING ( Batch to Batch Changeover):

3.1.1    Ensure that status label is updated as “TO BE CLEANED”.

3.1.2    Switch off the mains before cleaning the multimill.

3.1.3    Remove labels, materials and containers of previous batch from the processing area.

3.1.4    Remove any adhering material from the outer surface of multimill using vacuum cleaner.

3.1.5    Wipe out the adhered material from outer surface of the multimill using dry lint free cloth.

3.1.6    Record the cleaning details in equipment log sheet.

3.1.7    Take the line clearance from QA department before starting the operation.

3.2 Frequency of Type A Cleaning:

  •    Shall be performed between batch-to batch changeovers.
  •    At the end of a particular operation in the batch.
  •     At the end of the day.
  •    Before type “C”cleaning.

3.3    TYPE “C” CLEANING (Product to Product Changeover) :

3.3.1    Update the status label as “TO BE CLEANED”.

3.3.2 Switch off the mains of the multimill and cover all the electrical points with polythene cover.

3.3.3 Remove any material, labels and containers of previous product from the processing area.

3.3.4    DISMANTLING OF THE MULTI MILL PARTS:

3.3.4.1 Stop the dust extraction system.

3.3.4.2 Remove the feeding hopper with sliding lid and gasket by rotating the wing nuts in anticlockwise direction.

3.3.4.3 Remove the multimill chamber by unlocking the ring nuts and gasket.

3.3.4.4 Remove the perforated sieve (screen) and screen holding plate by rotating the ring nuts of the studs in anticlockwise direction.

3.3.4.5 Remove the rotor with the blades (16 nos knife/impact edged swinging type blades and two nos of scrapper blades) by unlocking the rotor-mounting bolt from the shaft. Remove the key and retaining pins holding the blades.

3.3.4.6 Transfer all the dismantled parts to the washing area after affixing “TO BE CLEANED” label.

3.3.5 CLEANING OF MAIN BODY AND AREA:

3.3.5.1 Remove any adhering material to the multimill body using vacuum cleaner.

3.3.5.2 Wipe the body with lint free cloth dipped in Purified water until no adherent material is seen. 

3.3.5.3 Finally wipe the multimill body with lint free cloth dipped in 70% IPA.

3.3.5.4 Remove the polythene cover fixed to the electrical points and wipe them with dry lint free cloth.

3.3.5.4 Wipe the walls, ceiling, door and glass with dry lint free cloth and mop the area with disinfectant solution.

3.3.6 CLEANING OF MULTIMILL PARTS:

  • Wash the parts with about 50L of purified water using nylon scrubber until no adherent material is visible.
  • Rewash the parts with about 30L of purified water.
  • Rinse the parts with about 30L of purified water.
  • Clean the gasket with purified water and then wipe with 70% IPA.
  • Dry the SS parts of the multimill in the IR drier, record the drying details in the IR drier logbook. Finally wipe with 70%IPA.
  • Transfer the cleaned and dried parts to cleaned milling area after affixing “CLEANED” label.
  • Assemble the dismantled parts in the reverse order of dismantling and update the status label as “CLEANED”.
  • Record the cleaning details in the equipment log sheet.

NOTE:

1.   Store the cleaned screen in a clean polythene cover and close the cover with tag and label it as “CLEANED” mentioning all the details given in the cleaned label.

2. Do not store more than one screen in one polythene cover.

3. Check the integrity of the screen before and after cleaning.

FREQUENCY of Type C Cleaning:  

  • After product-to-product changeovers.
  •   After continuous production of 6 days of the same product.
  • Major break down of equipment.
  •   If the equipment is idle for more than 30 days.

4.0         ABBREVATIONS

4.1           SS    – Stainless Steel.

4.2           QA   – Quality Assurance.

4.3           QC   – Quality Control

4.4           IR    – Infra Red

4.5           IPA  – Isopropyl Alcohol

5.0        REFERENCES

 Nil

6.0       ANNEXURES

  Nil

7.0       Distribution

This SOP (Controlled Copy & Display copy) shall be distributed to Manufacturing  department.

8.0       SOP Revision History record

Revision No.Details for Revision(s) with Change Control No.Effective Date (Sign. / Date)

SOP for Multimill

1.0       OBJECTIVE

  1. To lay down a procedure for the operation of Multimill.
2.0       RESPONSIBILITY
  • Technical Assistant – To follow the SOP.
  • Executive – To comply the SOP.

3.0       PROCEDURE

3.1 Check the cleanliness of the area and the machine.

3.2    Use cleaned scoops during the milling operation.

3.3   Get line clearance from QA department before starting the operation.

3.4     Remove the CLEANED” label and affix the “UNDER PROCESS” label to the multimill.

3.5   Procure all the materials of required quantity as per the BPRR to be milled in the milling area.

 NOTE: Use the screen as specified in the BPRR of that product.

3.6 SET-UP:

 3.6.1 FIXING OF ROTOR AND BLADES ASSEMBLY

 3.6.1.1 Ensure that blades are fixed in the rotor are in  sequence.

 3.6.1.2 Ensure that blades are fixed with their knife-edge in forward direction.

 3.6.1.3 Ensure that all blades are secured with retaining pins.

 3.6.1.4 Align the rotor with blades to the drive shaft.

  3.6.1.5 Fix the rotor with blades to the drive shaft with help of bolt.

  3.6.1.6 Tight the bolt with help of spanner. 

3.6.2   FIXING OF SCREEN:

3.6.2.1 Check the screen physically for its integrity.

3.6.2.2 Align the screen on the base plate  (Base plate has got circular groove to place the screen).                                             

 CAUTION:  Do not force screen holding plate on studs.

3.6.2.3 Fix the screen holding plate along with the screen on the two studs.

3.6.2.4 Tighten the two studs.

3.6.2.5 Close the slide valve by pushing inside.

3.6.2.6 Check that knives of the rotor are not touching the screen by turning the belt by hand / by inching.

  3.6.3    FIXING OF DISCHARGE HOPPER

 3.6.3.1 Check that gasket is properly positioned.

 3.6.3.2. Align the hopper with mounting bracket.

 3.6.3.3 Fix the hopper with the help of four Ring nuts.

 3.6.3.4 Tighten the Ring nuts with help of adjustable spanner / screwdriver.

3.6.4    FIXING OF CHARGING HOPPER:

  3.6.4.1 Check that gasket is in position.

  3.6.4.2 Align the hopper with mounting bracket.

  3.6.4.3 Fix the hopper with help of wing nuts.

3.6.5  OPERATION:

3.6.5.1  Put the power plug into the power supply socket. Switch on the mains. 

3.6.5.2  Check that machine is working properly and Switch on/off the mains.

3.6.5.3 Place SS container/IPC below the product outlet chute and Connect with dust free Interface.

3.6.5.4  Attach one end of dust free interface to the discharge hopper of multi mill  and the other end to the container/IPC mouth.

3.6.5.5 Transfer the material to be milled into IPC.

3.6.5.6 Lift the IPC with the help of the Material handling device (if material is in SS container/double lined polythene bag, add the material to be milled manually with the help of a SS scoop).

3.6.5.7  Position the IPC such that the discharge of IPC is on charging  hopper of multi mill inter connected with dust free interface.

3.6.5.8  Switch on the mains. Turn the switch for direction on the drive in the Anti clock wise direction for ‘Reverse’ direction and turn in clock wise direction for ‘Forward’ direction. To increase or decrease the speed use potentio meter knob.

3.6.5.9 Feed the material at constant rate and regulate the input by adjusting the butterfly valve of the IPC and sliding lid of feeding hopper.

NOTE :Dust free Interface can be food grade silicon bellow or lint free cloth.

CAUTION: 

1) Do not change the direction of rotation during the milling operation.

2) Wait for the machine to stop fully before changing the direction.

 3) Over feeding may jam the rotor and blades that may damage the screen.

3.6.5.10  Collect the milled material into IPC container and label accordingly.

3.6.5.11 After completion of the milling operation, Press the red push button to  stop the machine.

3.6.5.12  After ensuring that the machine is stopped, remove the screen and check its integrity.

3.6.5.13 Record the details of the operation in the BPRR.

 3.6.5.14 Affix a TO BE CLEANED” label after the completion of milling operation.

 3.6.5.15 Record the operation of the machine in the Equipment Log book.

4.0          ABBREVATIONS

                 4.1     SS         –  Stainless steel.

                 4.2     BPRR    –  Batch Processing Record.

                 4.3     Q.A.      –  Quality assurance.

                 4.4     Q.C.      –  Quality control.

                 4.5     IPC       –  Inprocess Container

 5. 0     REFERENCES

              5.1  Nil

 6. 0     ANNEXURES

              6.1   Nil

7.0       Distribution

This SOP (Controlled Copy & Display copy) shall be distributed to Manufacturing  department.

8.0       SOP Revision History record

Revision No.Details for Revision(s) with Change Control No.Effective Date (Sign. / Date)