Rustom Shams PDF
Rustom Shams PDF
Rustom Shams PDF
PRIMARY PACKAGING
Shams Rustom
Labopharm
Sr. Director, Product Development & Manufacturing
Outlines
What is primary packaging ?
Types of Primary Packaging
Selection criteria of primary pack mat for oral
solid dosage form
Packaging materials variables
Packaging process variables & troubleshooting
Packaging process validation strategy
Anti-counterfeit packaging
Global strategy & Regulatory requirements
Selection Criteria
Company Strategy & Goal (global or National?)
Convenience:
Glass is a perfect barrier to atmospheric oxygen, avoiding rancidness,
changes of colour & taste.
Glass is inert. No migration of components
PET bottles
HDPE Bottles
Convenience:
Light weight & Unbreakable
Comparatively better barrier
Inconvenience:
Migration of components may happen & may affect on product stability,
Identification Symbols
SYM
BOL
NAME
PROPERTIES
PET
HDPE
PVC
LDPE
PP
caps,
PS
OTHER
Density
(g/ml)
MVTR1
Oxygen2
Stiffness3
Impact
Resist
Hot Fill
Max (F)
PET-G
1.33
4.0
100
300
Fair
160
O-PET
1.36
2.0
75
450
Excellent
160
PET
(hot fill)
1.37
1.8
55
550
Excellent
188
PP
(polypropylene)
0.91
0.5
3,500
200
Fair
200
O-PP
(oriented)
0.91
0.3
2,500
250
Good
220
PVC
polyvinylchloride
1.35
3.0
150
300
Fair
160
HDPE
(high density
polyethylene)
0.96
0.5
4,000
150
Excellent
160
g/mil/100 sq in - 24 hrs,
cc/mil/sq m - 24 hrs,
PVDC
PCTFE
Alu
oPA
PE 25 micron
PVC 250 micron
PVC 250micron
Cl
PCTFE Laminations
Triplex Lamination
PCTFE
Adhesive
PE
PVC or
alternative
Duplex Lamination
PCTFE
Adhesive
PVC, PETG, BAREX, PP
Or even LDPE
Flat Sheet
Formed Blister
0.040
0.035
0.030
0.025
0.020
0.015
0.010
0.005
0.000
PVC/PE/PVDC 90gsm
PVC/PCTFE 15
ALU 45 micron
PVC 60 micron
Properties of COC
COC (Cyclic Olefin Copolymer) Film
Polyolefine skin
layer: PP, PE,
COC
Polyolefine skin
layer: PP, PE,
0.040
0.035
0.030
0.025
0.020
0.015
0.010
0.005
PV
C
/P
E/
P
VD
C
90
gs
m
0.000
Cooling Temperature
Perforation Temperature
Identify critical SKUs: based on unique size, shape & impact by the critical parameters
Establish critical parameters range: Low speed Vs High temperatures and Vice versa.
In case of multiple packaged SKUs, take a matrix approach to select the number of
batches or run of each SKU.
Validate the range of each critical process parameter during the run
PVC
Film heating
Lower than
PVC face
Cavity
Formations
Teflon avoided.
RT & Plug
assist
recommended
Sealing
Properties
Lidstocks
seals very well
Lidstocks seals
adequately
Lidstocks seals
poorly except
Novel lidstock
Generally 1702200
Higher temp
may cause
curling
Sealing
Temperature
(C)
PVDC
PCTFE
Curl
Causes
Higher TD shrinkage of raw PCTFE compared to PVC film (Up to 15% Vs~0)
Recommendations
1,866
$11.90
$6.38
0.31
0.020
2,028
$9.50
$4.68
0.23
0.015
1,860
$9.75
$5.24
0.15
0.010
1,730
$10.75
$6.21
0.11
0.007
1,528
$14.00
$9.16
0.07
0.005
1,355
$15.50
$11.44
0.05
0.003
PRODUCT
PRICE IN US$
0.020
~ $ 40 / Kg
0.015
~ $ 27 / Kg
0.020
~ $ 33 / Kg
0.015
~ $ 23 / Kg
push-through foils
Paper/Foil push-through structure.
Paper/PET/Foil CR peel-push structure.
Paper/PET/Foil CR peelable structure.
Anti-Counterfeit
Anti-Counterfeiting Technology in Blister
Films:
ACF films and foils incorporate UV Markers to
protect against counterfeiting.
Company logo or product brand logo can be
combined in the film and foil such that when
exposed under a standard UV light, the logo and
blister film illuminate to verify authenticity.
Anti-Counterfeit
Digital Imaging: e.g. Cryptoglyph
Fingerprints:
Several companies from USA & Europe have their patented technology
Global Strategy
Strategy for packaging materials based on
Compliance to different parts of the world
Stability study at the early development stage
Assurance of protection against different climatic
zones
Target markets requirement & their most popular SKU
Cost-effectiveness: Barrier (MVTR), Availability, Price,
Yield and Ease of thermoforming.
Example of Interchangeability
FDA Change Protocol
Regulatory Guidelines
Web site of FDA guidelines for submitting
documentation for human drugs & Biologics.
http://www.fda.gov/cder/guidance/package.htm
FDA guideline Container Closure Systems for Packaging
Human Drugs and Biologics.
Recapping
Select cost-effective pack mat at early stage of development
Appropriate barrier (MVTR) required for product in target market
HDPE bottle can be the best & cheapest choice if target market allows
Appropriate thickness & thermoforming yield for blister
PVC/PCTFE blister can be cost effective than PVC/PVDC & CFF
Availability from multiple vendors to keep purchasing flexibility & control
Compliance to global regulatory requirements & interchange ability
Anti-counterfeit Packaging
Select cost-effective anti-counterfeit packaging based on the need