1.3 Capsules and Effective Encapsulation - Shaikh Chand

7/23/2019 1.3 Capsules and Effective Encapsulation - Shaikh Chand

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and

Effective Encapsulation


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eaker

Shaikh Chand

. . . ec n ca erv cesACG Associated Capsules Pvt. Ltd.


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Contents :

1. Overview on Two piece capsules

a. Capsule Design

b. Manufacturin Process

4. Encapsulation machines

technology

a. T es of technolo

c. Sizes of Capsulesd. Quality Checks

e. Non conformitiesi. Types of Non conformities

ii. AQL

iii. Typical non conformities

b. Encapsulation troubles &counter measures

c. Most common issues while

encapsulation5. Storage/Handling precautions

for Empty capsules

Continual improvements in

Manufacturing process &

systems/new products

6. Q&A


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CAPSULE SHELLS


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DESIGN OF CAPSULE SHELLDESIGN OF CAPSULE SHELL

Note: This is only illustrative sketch. The design features varies with

supplier and their product range.


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DESIGN OF CAPSULE SHELLDESIGN OF CAPSULE SHELL

Note:

The Pre-Locked and Locked Length may differ for two suppliers,

hence filling machine settings are required to be adjusted as per Capsule

suppliers specifications.


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HARD GELATIN CAPSULES INGREDIENTS

ACG ASSOCIATED CAPSULESACG ASSOCIATED CAPSULES

Gelatin

Water

Colours & Titanium Dioxide Imprinting Ink


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CAPSULE SHELL MANUFACTURINGCAPSULE SHELL MANUFACTURING

1. Gelatin raw material is mixedin DM water at 80 deg centto form a viscous colourless

solution in Melter mixer2. The Clear solution is

dispensed in a smaller feed

tanks. Colourants are addedas per customer approval.

3. Lightnin stirrers used for

bubbles.4. Gelatin Solution is kept for

settling for De- Bubbling.


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Capsule moulding

HCM line clearance

PROCESS FLOWPROCESS FLOW -- MANUFACTURINGMANUFACTURING

Stripping, cutting, joining

Drying

Process & Product control

checks

In-process QC

checks

CompliesDoes not comply

Reject Printing / Packing

Automatic capsule transfer

Moisture stabilisation


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PACKING:

Primary : Food grade multi-layer co-extruded poly bag

2

PACKING, STORAGE AND HANDLINGPACKING, STORAGE AND HANDLING

STORAGE:

Temperature : 150 C to 300 C (590 F to 860 F)

RH : 40% to 65%

TRANSPORTATION :

Road : Temperature controlled A/C vans

Sea : Reefer Containers


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QUALITY SYSTEMQUALITY SYSTEM


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ININ--PROCESS QC CHECKSPROCESS QC CHECKS--MEASURABLEMEASURABLE

Single wall thickness

Outside diameter

Dome thickness

Shoulder thickness

Length


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DEFINITION OFDEFINITION OF

CAPSULE NON CONFORMITIESCAPSULE NON CONFORMITIES

Critical defect

capsule as package for the final product orcontributes to a major filling problem

Major defect Is a defect that may cause a problem on afilling machine

Minor defect

performance of a capsule as a package. Itis a slight blemish that makes the capsulevisually imperfect.


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CATEGORIZATION OFCATEGORIZATION OF

CAPSULE NON CONFORMITIESCAPSULE NON CONFORMITIESCritical defects Major defects Minor defects

Holes Loose ieces Minor s lits

Uncut cap / Body Closed capsules Minor rough cuts

Cracked / Split Double caps Minor collet pinches

Short body Bad join Minor punched dome

Double dip Major rough cuts BubblesTelescoped Major collet pinches Wrinkles

Trims Thin spots SpecksString on end Short cap Dirt marks

Long body StringsLong cap Scrapes / scratches

Grease / Oil rings


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SAMPLING PLAN & AQLSAMPLING PLAN & AQL

Visual defects are evaluated based on sample size & acceptance numberderived from the ISO 2859 Part I using single sampling plan.The AQLs indicated could be verified on a composite random sample drawn from

, .

Categorization

of defects

Lot size 500,000 & above

Sample size*Acceptance

numberRejectionnumber AQL % AOQL%

CAPSULE DEFECTS

r ca . .

Major 1250 1 2 0.04 0.067

Minor 1250 7 8 0.25 0.360

* To be selected from ( k + 1 ) cartons where k = number of cartons in the lot.


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TYPICAL NON CONFORMITIES


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Pin Holes / HolesPin Holes / Holes

-

Definition: Capsule, which has beenpierced on any part of its surface

Causes

o Mechanical touch durin Mould

strippingo Loose/Bend Mould pins


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BubblesBubbles

Definition: Capsule having bubbleeither on cap or body having

diameter more than 1 mm

Causes

o Preparation of Gelatin Solution


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Loose Cap / BodyLoose Cap / Body

Defect Classification - Ma or

Definition: It is a cap or body in un-joinedstate.

Causes

o Two parts not joining on Capsule

o Capsules becoming Loose during postmanufacturing activities


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Metal ParticlesMetal Particles

Causes

o Metal to Metal Friction onmanufacturing machines

o Impurities in Gelatin /Dyes


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Black SpotsBlack Spots

Defect Classification - Minor

Definition: Capsule having

speck/Spots either on cap or bodyhaving diameter more than 1 mm.

Impurities in Gelatin solution/ Dyes


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Cracked/Splits/TelescopedCracked/Splits/Telescoped

Defect Classification - Critical

Definition: Capsule having longitudinal break infilm straight or spiral, from the edge of cap orbody cut end.

Capsule with Cap/Body partially cut duringjoining

Causeso Capsule joining defect (On filling machine or

in Empty capsule)


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ENCAPSULATIONENCAPSULATION

TECHNOLOGYTECHNOLOGY

TYPES OF ENCAPSULATIONTYPES OF ENCAPSULATION


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TYPES OF ENCAPSULATIONTYPES OF ENCAPSULATION

TECHNOLOGYTECHNOLOGY

Capsule FillingMachines

Hand Filling Semi Automatic Automatic

Intermittent Rotary

Dosingprinciple

Tampingprinciple

Dosingprinciple


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ENCAPSULATION TROUBLESENCAPSULATION TROUBLES

AND COUNTERMEASURESAND COUNTERMEASURES


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CAPSULE ORIENTATION LOADING ANDCAPSULE ORIENTATION LOADING AND


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CAPSULE ORIENTATION, LOADING ANDCAPSULE ORIENTATION, LOADING AND

SEPARATIONSEPARATION

capsule separation.

Too high vacuum can cause the Cappart of capsules to pop out afterseparation.

Dome part of Body may come apartdue to high vacuum.

CAPSULE ORIENTATION LOADING ANDCAPSULE ORIENTATION LOADING AND


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When loading into upper bushes/Capsegments, the capsules should not hit to the

CAPSULE ORIENTATION, LOADING ANDCAPSULE ORIENTATION, LOADING AND

SEPARATIONSEPARATIONcontdcontd

e ges.

For correct rectification and loading, adjust thepositioning of capsules in rectification Block by

Horizontal fingers.

Adjust the opening time of vacuum when ittouches the bottom part of Body bushes. Itshould not be delayed time.

UNOPENED CAPSULES REJECTIONUNOPENED CAPSULES REJECTION


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(NON SEPARATION)(NON SEPARATION)

Verify if Non Separated capsules are tight to open whenpu ng apar

Check the vacuum for capsule separation. Get as perrecommendation of Machine supplier

Plug the losses of Vacuum from Vacuum line

Clean the filter bags Verify the alignment of Cap and Body Bushes.

separation and if so correct the machine settings.



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(NON SEPARATION).(NON SEPARATION).contdcontd

or emp y capsu e separa on, e es re vacuum range orAutomatic Filling (AF) machines is 16 to 24 (400 mm to 600mm) of Hg and the Vacuum valve should be operative withcorrect timing.

For Multi Ejector pump, (operated on Compressed Air) Vacuumpressure should be between 0.2 to 0.3 bar and Inlet Air should

e g q. cm

CAPSULE CLOSING (SPLITS/DENTS)CAPSULE CLOSING (SPLITS/DENTS)


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Common Causes of Denting

1. Capsules are closed to lower than.

2. Cap and Body segments are notaligned. (Use alignment pins for verification and correction)

3. Closing pins are not in the center of bushes.

4. Flat Closing Pins Concave is better5. Overfilling



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Common Causes of Splits/Telescopes

1. Excessive gap or No gap between Cap

dome of capsule and closing plate orTop pin2. Abrasive Powder/No slug Formation3. Closing pins are not in the center of

bushes.4. Cap and Body segments are not

aligned. (Use alignment pins forverification and correction

5. Misalignments during running of themachine due to wearing of machineparts / loose fitted parts

CAPSULE CLOSING (SPLITS/DENTS)CAPSULE CLOSING (SPLITS/DENTS) tdtd


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Enlar ed internal sizes of se ments

CAPSULE CLOSING (SPLITS/DENTS).CAPSULE CLOSING (SPLITS/DENTS).contdcontd

or Bushes can cause Splits/ Foldingor breaking in filled capsules.

Assessment of Wear and Tear is

recommended

PRECAUTIONS ON AUTOMATIC FILLINGPRECAUTIONS ON AUTOMATIC FILLING


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PRECAUTIONS ON AUTOMATIC FILLINGPRECAUTIONS ON AUTOMATIC FILLING

MACHINESMACHINES

Filled Capsule Ejection :

See that the ejection issmooth.

Cap denting or damaging isgenerally seen whenalignment is not proper or

capsule.


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SERVICESSERVICES

YOUR GLOBAL PARTENER IN SOLID DOSAGE SYSTEMS


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SERVICE INFRASTRUCTURESERVICE INFRASTRUCTURE

Sales and Customer Service

Technical Service Regulatory Support

Product Development

YOUR GLOBAL PARTENER IN SOLID DOSAGE SYSTEMS

REGULATORY SERVICEREGULATORY SERVICE


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REGULATORY SERVICEREGULATORY SERVICE

Support offered :

Documentation

Queries

Color shade development center

Access Letters Empty Hard Capsules

Printing Ink Dedicated Regulatory Cell for ANDA business

TECHNICAL SERVICETECHNICAL SERVICE


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TECHNICAL SERVICETECHNICAL SERVICE

Experts in capsule machine interface

Pro-active visits to customers

Enable customers to improve productivity

Training on encapsulation machines on shop

floor

Develo ment of customized solutions

Support on scalability & interchangeability offilling machines

APPLICATION DEVELOPMENT LABAPPLICATION DEVELOPMENT LAB


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Facility at Mumbai -

APPLICATION DEVELOPMENT LABAPPLICATION DEVELOPMENT LAB

75 % RH Simulated studies are performed Studies on Color Compatibility Multi-media dissolution studies Dissolution & tabilit studies on new

capsules product Liquid in Hard Gelatin and HPMC capsule

trials


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CAPSULE SHELL HANDLINGCAPSULE SHELL HANDLING

PRECAUTIONSPRECAUTIONS

HANDLING PRECAUTIONSHANDLING PRECAUTIONS


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Avoid damages to Empty capsules while transfer and handling.

a e e ags or con a ners con a n ng capsu es proper y so athere is trace ability of batch/vendor.

Maintain Capsule filling conditions for temperature 20 C to 25 C

and 45 % to 55 % RH.

Issue / take capsule boxes preferably in sequence or nearby box. , , , . , , ,



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Always seal the capsule bags airtight after sampling & dispensing.

Keep the capsules containing boxes away from the adjacent wallsand also from the ceiling.

Use only S. S. scoops & spatulas having smooth, blunt and

rounded edges. Plastic material develops Static charge on use.



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Even for brief period, do not store the capsules near a source of

heat.

Avoid wide temperature fluctuations during storage and handling.



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Do not leave the capsules in hopper of capsule filling machine.

Colour fading can also occur if the capsules contain lightsensitive dyes are exposed to light for longer time.

Dont use plastic scoops /containers for capsule transfer orcollection as they develop static charge.

SummarySummary


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yy

Prevent leakages of vacuum from Vacuum lines upto theseparation point of empty capsules.

.(Generally provided by Machine supplier)

For Hygroscopic and sticky powders, clean the bushes

and machine parts at frequent intervals. Clean the filter bags at regular frequency.

Finer adjustments on machine settings can result intoeliminating chances of variations in performance fromBatch to batch.

FILLING MACHINES COMPARISON :FILLING MACHINES COMPARISON :


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SPEED VS OUTPUTSPEED VS OUTPUT

The high output machine may not necessarily be thehigh-speed machine.

More no. of strokes per minute means lesser contact timefor capsules to open and close. Hence, machine settingsbecome more critical and essential for such machines.

Proper vacuum is essential particularly for High Speedand High out put machines.

( Get and maintain as per machine manufacturersspecification.)

FILLING MACHINES COMPARISON :FILLING MACHINES COMPARISON :


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6 x 1= 61PAM - AF40 T

Theoretical output/

HourStrokes/Min

No. of capsules for

each stroke

Loading

stationsMachine Type

SPEED VS OUTPUTSPEED VS OUTPUT

=-

40,0001355 X 1 = 51Bosch - GKF 700 S

135,0001408 x 2 = 162Seejong - 135

100,0001207 x 2 = 142Seejong - SF100

70,000986 x 2 = 122Seejong - SF70

150,0001409 x 2 = 182PAM - AF150 T

90,0001087 x 2 = 142PAM - AF90 T

,

150,0001359 x 2 = 182Bosch-GKF 2000

200,00013513 x 2 = 262Pam - AF 200 T

84,0001405 x 2 = 102Bosch - GKF 140040,0001126 x 1 = 61IMA -Zanazi 40 F

,

Empty gelatin capsulesEmpty gelatin capsules


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Widest possible range of sizes

available :

p y g pp y g p

Sizes : # 000 (Biggest)

#00, # 0, # 1, # 2, # 3, # 4 &

# 5 (Smallest)

S ecial sizes - # 00EL # 0XEL # 0EL

# 0EL+, # 1EL, # 2 EL

Shades : Over 5000

ACG Capsule sizes


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ACG Capsule sizes

HPMC capsulesHPMC capsules


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NATURE CAPS

Low moisture capsules

Specially designed for high -

speed automatic machines

FLOFITFLOFIT


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Capsules forCapsules for Liquid filling

AN ALTERNATIVEAN ALTERNATIVETO SOFT GEL CAPSULESTO SOFT GEL CAPSULES


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TO SOFT GEL CAPSULESTO SOFT GEL CAPSULES

Liquid filling in hard gelatin & HPMC capsules & band sealing of capsules

u oma c an ea ng ac ne


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INNOVATIONINNOVATIONNew product offerings

CLINICAPS


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CLINICAPS capsules allows blinding of- -

or other capsules.

Simply fill the capsules manually, or on

conventional filling machines

, , ,

Shorter length facilitates ease ofswallowing

MARINECAPS (Fish Gelatin Capsules)MARINECAPS (Fish Gelatin Capsules)


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Being non-ruminant material, it does not pose the risk ofBSE/TSE.

Not a suspect material for BSE/TSE under regulation EQN999/2001& further amendments to EuropeanPharmacopia.

Low water vapor transmission rate.

Low oxygen permeability.

TD Caps : Capsules for Dry Powder

I h l ti ( DPI )


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Inhalation ( DPI )Regular capsules DPI capsules

Product requirement :

- Low powder retention- Clear capsules after dosing- Capsule retention shall be less than 5%- DOED shall be not less than 25% by TSLI method- Non reactive lubricant

DOED deposition of emitted doseTSLI - Twin stage liquid impinger

SPECIAL SIZES OF CAPSULES


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Gelatin capsules- available in special sizes, namely

size # 000 00el 0Xel 1el 2el 5

Customized sizes of capsules can be made available

as a joint development project

PEARLZ CAPSULES


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PearlzPearlz ca sules ca sules -- with awith a

unique shine to give yourunique shine to give yourbrand stand outbrand stand out

Available in HPMC & GelatinAvailable in HPMC & Gelatincapsulescapsules

PROMOTINGPROMOTING

ANTIANTI--COUNTERFEIT MEASURESCOUNTERFEIT MEASURES


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Oriented Circular Printing 2 Color Print on capsules 360 degree printing

PROMOTINGPROMOTING



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First Time GLOBALLYFirst Time GLOBALLY

Brand Shield 4 C (4 Color Printing)

REGULATORY MARKET SUCCESS


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More than 100 capsule molecules underqualification process with 50 generic

manu acturers

Partnering with 4 of the top 5 Global generic

companies

Strategic supplier for MNCs for Site transferproducts in India


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THANK YOU

Date post:	15-Feb-2018
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1.3 Capsules and Effective Encapsulation - Shaikh Chand

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