Training on Printing & Mixing of

Capsules
Printing of Capsules
 Pre-Requisite

Following Measurement should be taken before starting of Printing

Process
 Clear the previous product remaining
 Clean printing machine with IPA (70%)
 Confirm the printing Ink, printing mold, and the product to be
printed as per BMR.
 Lux level should be between 500-1000 Im/m2
 Line clearance should be awarded by QA Personnel.
 Line Clearance
Before the starting of process line clearance should be confirmed by the QA during line
clearance following parameters should be checked
 There should be no traces of previous product in:
•Area
•Equipment, Scoop, Cabinet
•Containers
•Printing machine
 Container & machine should be properly labelled with identification label.
 Area, equipment, containers & machine should be cleaned.
 Log books should be maintained.
Approved BMR Should be available.
Personnel should wear clean uniform, gloves & mask.
 Temperature & humidity should be in limit i.e. 15-25°C & 35-65%RH
Respective mold and printing ink should be verified by QA & Production.
Line clearance must be awarded by QA Personnel.
 Procedure For Printing
 Install the printing mold, pour a certain amount of ink into the printing plate, add a small
amount of IPA (99.9%) and stir it fully.
 Add the hollow capsule to be printed in the hopper and start the printer.
 Checking of printed sample by section-in-charge and QA Officer and after confirming that
the sample meets the requirements before continuing the printing process.
 Timely add ink and IPA (99.9%) in the printing process.
 After completion of printing process sent product to the next stage.
 Update all the record related to printing.
 In-Process Monitoring

 The machine operator check the sample regularly and monitors it through
the lens under the light.
 Production & QA officer checks the capsules after every hour through lens
and place entry in BMR.
 Printing error will be record in in-process monitoring sheets (BMR)
 Precautions

 Shake well before using printing ink.

 Check the expiry date before using printing ink.
 Collect intact blade after use.
 Monitor & Change blade from time to time.
Mixing of Capsules
 Introduction
Mix UP
Mix up can be defined as taking something which is not subject to take; taking on thing
to another. Taking wrong item unintentionally which can be easily identified such as
missing of different color or different sizes capsules. Mix up is:
• Assume wrong item to right thing.
• Failure to take action on due time.
• Mixture of various item/elements.
• Selection of wrong item.
• Selection similar product/material/item.
• Unintentionally taking one thing to another.
• Wrong selection of desired material.
• Wrong action taken due to lack of attention.
 Causes of Mix Up
Following are the some probable cause of mix up:
• Breakdown of processing equipment.
• Collation/Procure similar packaging/printed material form same vendor.
• Engaging untrained/partial trained personnel.
• Engaging single operator to multiple lines.
• Failure to follow written procedure for line clearance.
• Inappropriate labelling.
• Improper segregation of product/item during manufacturing operation.
• Manual operation other than automated system.
• Rejection material handling.
• System failure.
 Contamination
Definition:
Contamination can be defined as the presence of undesirable element,
impurity or constituent which infects, corrupts, spoils, makes
substandard or make unhealthy a factory, normal environment,
physical body, material, process steps, bulk, liquid, granules, solid etc.
Types of Contamination
Non-Viable
Liquid or solid particulate contamination range from 001 and 1000
microns such as smoke, dust, fogs, fumes and mists.
Viable.
Particulate contamination that supports or consists of one or more live
 Sources of Contamination
Following are the main sources of contamination:
• Atmosphere
• Clothing
• Equipment
• Fluid
• HVAC System
• Manufacturing debris
• Premises
• People
• Processing operations
• Surfaces
• Utilities & services
 How to avoid mix up
Following are the strategies to avoid mix up:
• Establish and Enforce strict Protocols.
• Practice effective personnel hygiene..
• Utilize personnel protective equipment properly.
• Designate separate workspaces and equipment.
• Trained and educate personnel.
• Product should be physical segregate and labeled with identification labels.
• There should be only one product in area at a time.
Thank you!