Charging of plastic granules

Charging of plastic granules

• PURPOSE

To lay down the procedure of charging of plastic granules in FFS machine.

2.0      SCOPE                                  

This SOP is applicable for charging of plastic granules in  FFS machine  at SVP section 

3.0       REFERENCE(S) & ATTACHMENTS

3.1       References

3.1.1    In-House

3.2       Attachments

3.2.1    Attachment: I  Granule Tank cleaning record

4.0      RESPONSIBILITY:

4.1       Production  Person:

4.1.1    To verify that employees are trained before performing or operation any task relevant to this SOP.

4.1.2    To perform the operation.

4.2       Production Head:

4.2.1    To ensure the compliance of SOP.

4.3       Quality Assurance Persons:

4.3.1    To verify that all the instructions are followed properly as per the given SOP.

4.3.2   To ensure implement of the SOP.

5.0      DISTRIBUTION:

1. Production
2.  II.   Quality Assurance.

6.0       DEFINITION & ABBREVIATION(S):

6.1       Definition 

            N/A

6.2      Abbreviations

6.2.1    SOP                : Standard Operating Procedure

6.2.2    QA                   : Quality Assurance

6.2.3    PROD.              : Production

6.2.4    C.C. No.          : Change Control Number

6.2.5    SS                   : Stainless Steel.

6.2.6    WFI                 : Water For Injection

6.2.7    FFS                 : Form Fill Seal

6.2.8    IPA                  : ISO Propyl Alcohol

6.2.9    BMR                : Batch Manufacturing Record

6.2.10  MAL                : Material Air Lock

6.2.11  SAP                 : System Application & Product in data processing

6.2.12  LAF                 : Laminar Air Flow

6.2.13  LDPE              : Low Density Poly Ethylene

7.0 PROCEDURE

7.1 Charging of Plastic granules

7.1.1      In FFS machine(BP-301) LDPE granules(Low Density polyethylene) is charged to form the container/ampoules of different shapes and size.

7.1.2      Granules will be used from approved vendor only.

7.1.3      Always keep adequate stock of approved LDPE granules in warehouse in sealed bags of 25 kg.

7.1.4      If any bag is opened, torn or damage, will not be use & considered as rejected bearing red              colour “ REJECTED” label.

7.1.5      Granule bags should be properly arrange on pallets in primary packing material room and should be approved by qc before use bearing “APPROVED” label.

7.1.6      Issue the granules (primary packing material) against SAP generated requisition slip as per  the batch quantity.

7.1.7      Store/ware house person in presence of QA dispense the granules in intact bag & transfer  the dispensed quantity in material air lock (MAL) of granules charging room.

7.1.8      Before charging production operator will clean the issued bag thoroughly from outside with  lint free cloth soaked In 70% IPA solution.

7.1.9      Charging of granules will be performed under vertical LAF & LAF should be continuously run during overall charging process.

7.1.10    To charge the granules in granules tank, person will enter in the charging room through personal air lock, wear gloves & mask & sanitize hands with IPA 70 % v/v solution & enter in the granule charging room.

7.1.11    Open the lid of SS granule tank & cut the bag with ss seizer or surgical blade from corner and transfer the granules carefully in the SS tank up to the mark & close the lid tightly.

7.1.12    After charging remove the empty bags from the charging room & clean the tank from out side with IPA 70% solution & floor with plastic broom to remove any of spillage.

7.1.13    During operation of FFS machine, granule will be continuously transfer to machine hopper               through flexible granule pipe by sucking with vacuum pump of FFS machine.

7.1.14    As the granule filled up to the maximum level in machine hopper, pump will automatically stop & granules transfer will stop, as the granule level get down up to minimum level, the granules sucking will be start & the process continuously run.

7.1.15    After completion of batch, switch off the granule feeder  to stop granules charging.

7.1.16    Reconcile the remaining granules(not physically) by calculating the of number of good &               rejected containers produced and  record in the BMR.

• Cleaning & precaution:

7.2.1      Granule charging room should be clean twice in a shift & whenever required.

7.2.2      Daily startup & end of the day clean the granules tank from outside with IPA 70% v/v solution soak lint free cloth.

7.2.3      Every month clean the granules tank from inside & outside by removing all granules from the tank & maintain the record as Attachment-I.

7.2.4      Keep the LAF always free from any dust particles.

7.2.5      As per the schedule clean the pre filter of the LAF as per SOP.

7.2.6      Daily verify the granule pipe physically to avoid any of breakage or leakage. 

7.2.7      Granules bags should be properly clean before use.

7.2.8      After dispensing granules bag should be stack on s.s pallets.

8.0        REVISION HISTORY

Attachment – I

Granule Tank  ID…….                                                 Location……..

Frequency: Outside cleaning on daily basis & overall outside & inside cleaning on monthly basis.