Glass Primary Packaging Trends

Carlos Navarro

Connecting People, Science and Regulation®

Why glass?

PHARMACEUTICAL ENGINEERING
SYSTEMS SYSTEMS

GLASS SPECIALTY PHARMA PACKAGING,

GLASS ASSEMBLING &
PRIMARY PLASTICS & INSPECTION
PROCESSING SERIALIZATION
PACKAGING DELIVERY DEVICES SYSTEMS

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 Expertise

Full portfolio (ampoules, Expertise on manufacturing Innovative solutions Full Range of Sterile products
cartridges, syringes, vials) cartridges for insulin for Biotech (vials, cartridges and
from glass tubing syringes)

Leader in converting 100% Dimensional and Full range of Automatic Assembly, Packaging and
technology Cosmetic Controls by Camera Inspection Machines Process Equipment

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OMPI do Brasil

30 milhoes de
Euro de
investimento

40 mil mq de
terreno

12 mil mq de
área construída

15 linhas de
produção

Cartuchos e
Ampolas

200 Funcionarios

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Range of Products today

Bulk Containers Ready-to-Use Containers

(Sterile)

ampoules vials syringes cartridges Special vials syringes cartridges

devices

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 OMPI portafolio critical to Quality

Technological and
Quality Solution Level
Market Needs

Benefit/Value
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OMPI Fina – Use & features

Technological and
Quality Solution Level
Aim for Parenteral Drugs

Intended Use
• Vaccines
• Diagnostics
• Small Molecules
• Anti-coagulants (i.e. Heparin)
• Anesthetics
• Veterinary
• Insulin
• GLP-1
• WFI/Diluents
• Other Pharma applications
• Cosmetics

Request for:
• Suitable for a wide range of
applications
High Quality

Benefit/Value

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OMPI Nexa – Use, Features & Benefits

Technological and
Quality Solution Level

Intended Use
• Biologics
• Large Molecules
• Sensitive Drugs
• Insulin & GLP-1
• Hormones & Proteins
• Adrenaline & Emergency
• Auto-injectors
• Drug Delivery Systems
State-of-the-art
Request for:
• High dimensional process
capability
• Higher Mechanical Resistance to
minimize breakage issues

Benefit/Value

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 How the Pharma
Market is changing?

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 Market Segmentation – Brazil

Source: Stevanato Group Marketing & Business Intelligence

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 Market Scenario – Challenges and new needs

High Costs Cost Pressure

for Developing
new drugs
! • Reducing capital investment,
• Reducing waste
• Reducing TCO

Increase Flexibility
• Reducing time to
Patent
Losses
! market
• Increasing business
opportunities
• Differentiation

Niche Market vs
Blockbuster ! Outsourcing of «non
core» activities
• Core pharmaceutical activities:
• Research
• Fill/Finish
• Marketing

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 Global Market Growth Estimation 2013 - 2018
Small Volume Parenterals (up to 50 mL)

Source: PDA Presentation of Dr. Friedrich Haefele, Boehringer Ingelheim Pharma GmbH & Co. KG

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Glass is the ideal material for parenteral packaging; even if has
some limitations these can be mitigated

CHALLENGES SOLUTIONS

• Use forming and converting best practices

• No Glass-to-Glass and Glass-to-Metal
Breakage contact to reduce flaws
• Glass strengthening
• Surface treatments

• Enhanced and optimized process

techniques
• Thermal cycle optimization with low
Delamination heat/energy forming process
• Test method to guarantee the quality and
the stability of vials production

• Integrated needlestick protection

Needle stick capability
• Passive protection

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Glass breakage

• Standard converting
technology can induce
flaws
• Flaws concentrate the
stress locally, decreasing
the overall
strength of the glass
• When a load is applied,
e.g. during the injection
with a pen injector, the
critical defect could
trigger the failure in the
glass leading to the
breakage of the whole
component

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 Platforms to improve product performances

Use forming and converting

best practices

No Glass-to-Glass and Glass-

to-Metal contact to reduce
flaws
Vials–Cartridges-Syringes

Improved Camera Inspection

Optimized containers manufacturing

process with an higher cosmetic quality
and stronger mechanical resistance

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Vials – Critical Defects

CRITICAL DEFECTS BODY SHOULDER COLLAR NECK MOUTH BOTTOM

Contamination X X X X X X
Scratches X X - - - X
- X X X X X
Folds /
Deformations
Bubbles - X X - - -
Pressure marks - - X X - -
Airlines X - - - - -
Chips / Cracks X X X - X X

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Have a high dimensional process capability

COLLAR NECK/MOUTH SHOULDER BOTTOM

Compatibility Blowback Optimized for High stability
with caps and repeatibility Inspection, of the vials on
filling lines to reduce the transport
false rejects belts

Freeze-dryed
drugs

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 Syringes – Very High Cosmetic Quality

Linear Scan - Shoulder

Cone Inspection

Linear Scan - Body

Area/Matrix Scan
Linear Scan (Internal Channel)
Area/Matrix Scan
Flange

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Syringes – High dimensional process capability

Cone Dimensions (Inside and Outside)

Flange Dimensions
Total Length

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Syringe – Features needed

Low Optimized
UV Curing
Tungsten siliconization

OMPI MAX
LIM [ppb]

Tungsten
0
free
Low
< 500
Tungsten

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 Syringe – Features needed

Siliconization Controls
• Presence of silicone inside the barrel
• Correct distribution inside the barrel


x
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Glass Delamination

• Separation of thin
glass layers (lamellae)
that appear as shiny,
needle shaped particles
floating in the contact
liquid
• The formation of a
silica-rich layer poorly
bonded to the substrate
is the first stage of an
extended delamination
• Glass-liquid
interactions are
responsible for the
formation of an altered
R.G. Iacocca et al., layer
AAPS Pharm.Sci.Tech. (2010)

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The Answer for Glass Delamination

Thermal cycle optimization

with low heat/energy
forming process

Low Delamination
Propensity
Qualitative test method to
guarantee the quality and the
stability of vials production
fully aligned with USP 1660

Optimized vials manufacturing process

with an higher quality product from
chemical point of view

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 Needle stick injuries & evolution of needle safety devices

1st Generation 2st Generation

Devices Devices PFS Integrated
Early Devices (add-on) (add-on) Devices

Manually Activated Automatic Activation Passively Activated Passively activated

and preassembled
User must manually Needle is shielded Requires no Provide added
activate the needle automatically; additional action by benefits
shield; additional activation step the user; safety preassembled in
movement and required to deploy mechanism ready to use format
manipulation of safety mechanism activated activated
device to activate upon administration
the safety feature of the injection

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Safety Systems - (ISS) designed to meet the needs of all drugs
(Biotech, Heparine, Vaccines)

Standard primary
packaging

Fully passive
protection

A standard ready to fill syringe with

integrated needlestick protection capability

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How is the market changing

FILL
PATIENT
FINISH

It is no longer about
stable production alone.
Production facilities must be ready
for adaption to changes in corporate strategy,
in market dynamics and in short-term targets.

SOURCE: NNE PHARMAPLAN

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Industry change as an opportunity to compete

“The success of a manufacturing site is moving

from site stability to site agility:
in addition to maintaining stable production, pharmaceutical
sites are now required to accommodate more changes and
deliver on unexpected targets”
SOURCE: NNE PHARMAPLAN

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How to be faster?

SITE STABILITY SITEAGILITY

FILL
FINISH

• Mono Product • Multi Product

• Core and Non core Activities • Only Core Activities
• High Capex • Very Limited Capex
• High Running Costs • Reduced Running Costs

Big Size Flexibility

Full Process Fast Reaction

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A Comprehensive Range of RTU Containers

Vials

Washing
Cartridges
(Siliconization)
Nest & Tub
Depyrogenation
Nesting (no G2G)
Final Sterilization
Syringes

Vials

Tray
Cartridge Only
Glass

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 What the market is looking for?

Productivity flexibility

Tray for dedicated filling line Nest&Tub for combo line

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 How PharmaCo Value Chain Changes

Value Chain:Roles & Responsabilities

Minimizing
Packaging
T.C.O. Packaging Industry: PharmaCo
Industry:
Pharmaceutical needs

Increasing Packaging Washing Sterilization Filling

Quality

Increasing
Flexibility Validation and Upstream
Capex
Regulatory Operations More
Resources
«non quality»
Costs and issues
Available
Reducing
Time-To-Market

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 PharmaCo Value

Reduction of initial investments on:


• Equipment (washing, WFI system, tunnel)
Minimizing • Utilities (WFI, kWh,..)
T.C.O. • Workforce
• Validation
• Maintenance

Cost Reduction for PharmaCo


Pharmaceutical needs

• No-glass-to-glass contact during transport

Increasing
• Feeding, Washing, Depyrogenating Tunnel are
Quality very stressed phases for packaging


• A unique fill&finish equipment for different
Increasing packaging
Flexibility • Easy & fast change packaging/format in the
same machine (combo line)


Reducing • Reduction of the time, using Ompi EZ-fill®
Time-To- from research to industrial scale
Market

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 Thank You for Your Attention!
Further information: [email protected]

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