Cleaning and Operation of NFD System

 In this post Standard Operating Procedure Cleaning and Operation of NFD System in Pharmaceuticals is describe.

1.0   OBJECTIVE:

To lay down a procedure for cleaning and operation of NFD system

2.0   SCOPE:

This procedure is applicable for cleaning and operation of NFD system installed in Strip packing machine of production department.

3.0   RESPONSIBILITY:

Technical Associate- For cleaning and operation. 

Officer/Executive Production - For supervision. 

Head Production -To ensure compliance of the SOP.

4.0   DEFINITION(S):

NA

5.0   PROCEDURE:

5.1   Cleaning

TYPE A CLEANING:

Change over from one batch to next batch of same product and potency.

5.1.1   Ensure that all the detail of previous batch are deleted from the MMI.

5.1.2   Remove the ‘UNDER PROCESS LABEL’ and affix ‘TO BE CLEANED LABEL’ with sign and date of production officer.

5.1.3   Switch ‘OFF’ all the utility supply before cleaning.

5.1.4   Clean the control panel with clean and dry lint free cloth.

5.1.5   Clean the top and outer surface of NFD panel with lint free cloth.

5.1.6   Replace the ‘TO BE CLEANED’ label with ‘CLEANED’ status label with sign of production and PQA officer.

5.1.7   Record the cleaning activity in equipment usage log sheet as per SOP.

5.2    TYPE B CLEANING:

This is a cleaning procedure for changeover of product with different activities/color/descending potency or ascending potency/when same product processed for more than a week or after maintenance.

5.2.1   Ensure that all the detail of previous batches are deleted from the MMI.

5.2.2   Remove the ‘UNDER PROCESS LABEL’ and affix ‘TO BE CLEANED LABEL’ with sign and date of production officer.

5.2.3   Switch ‘OFF’ all the utility supply before cleaning.

5.2.4   Clean the control panel with clean and dry lint free cloth.

5.2.5   Clean the top and outer surface of NFD panel with lint free cloth followed by mopping with 70 % IPA solution.

5.2.6   Replace the ‘TO BE CLEANED’ label with ‘CLEANED’ status label with sign of production and IPQA officer.

5.2.7   Record the cleaning activity in equipment usage log sheet as per SOP.

5.2.8   OPERATING PROCEDURE:

5.2.9   Switch ‘ON’ the NFD system.

5.2.10  On ‘MMI’ of ‘NFD’ the following icon appeared Buzzer, Monitor and Menu

5.2.11  Press buzzer and ‘ON’ buzzer for NFD reject.

5.2.12  After setting of NFD press ‘MONITOR’ to see the details of NFD reject.

5.2.13  Press ‘MENU’ to NFD setting of the machine.

5.2.14  Three USER icons appear on the screen-Operator, Supervisor and administrator.

5.2.15  Set ‘NFD’ in operator user by entering the password.

5.2.16  Five steps for ‘NFD’ setting opened in operator mode.

5.2.17  Toes: Enter the number of strip in one cycle by pressing the ‘□’

5.2.18   Number of track: Enter the number of strip from sensing to flapper by pressing the ‘□’

5.2.19   Sensor Count: Enter the number of tablets sensed by each sensor by pressing the ‘□’

5.2.20  Column/Track: Enter the number of sensor used in one strip sensing by pressing the ‘□’

5.2.21  Sensor Delay: Time to avoid the fluctuation of sensor by pressing the ‘□’

5.2.22   Rejection Length: Enter the number of strip from sensing roller to flapper by pressing the ‘□’

5.2.23   Flapper Setting: Enter the track wise flapper selection on the basis of number of track used.

6.0   ABBREVIATION(S):

SOP : Standard operating procedure No.  : Number

BPR : Batch Packing Record QA  : Quality Assurance

7.0   REFERENCES(S):

SOP: Status labeling

SOP: Making entries in equipment usage and cleaning log sheet

8.0    ANNEXURE (s):

Nil

9.0   DISTRIBUTION:

9.1    Master Copy    : Quality Assurance

9.2    Controlled Copy (s): Production department, Quality Assurance

9.3    Reference Copy (s) : Production department (02 copies).