How can Ompi EZ-fill® ease your business?

More FlexibilityIts ready-to-fill format leverages the different container fill-finish processes by using a common multi-product line.By joining Ompi EZ-fill® platform, SGD Pharma adds new solutions in vials filling.

Less time to marketIt is the perfect solution to be managed both during clinical trials and during the industrialization phase.

Increased quality and safetyUnique SGD Pharma Asolvex® Type I molded glass minimizes interaction risk. The specific design of the tray and the final packaging solution prevent the sterile molded vials from both particles and cosmetic aspects, reducing breakage during storage, transport and handling.

Reduced Total Cost of Ownership (TCO)It allows pharmaceutical companies to outsource their non-core activities, to lower footprint, to reduce costs related to personnel and utilities.

PharmaCo

SterilizationWashingPrimary Packaging Filling

STERILE READY-TO-FILL MOLDED VIALS

featuring

“We are pleased to welcome SGD Pharma as our first partner on the Ompi EZ-fill® platform. Our goal is to offer a complete range of sterile primary packaging to answer the expectations of pharma and biotech companies in ready-to-fill solutions.“

Alessandro MassignaniOmpi EZ-fill® Vials & Cartridges Product Manager

SGD Pharma joins

platform to offer sterile and depyrogenated high quality

molded vials.

the

INSPIRING CONFIDENCE

A proven process

Incoming materialParenteral containers for injectable drug products are produced and 100% inspected in clean room environment. The SGD Pharma high quality molded vials undergo incoming inspections that are necessary to declare them suitable for Ompi EZ-fill® process. SGD Pharma’s vials are supplied to the Ompi EZ-fill® area.

WashingContainers are washed into the washing machine with WFI (Water For Injection) and dried in an ISO8 class.

DepyrogenationVials are depyrogenated in a pharma tunnel that is working accordingly the Pharmacopea requirement.

Tray loadingContainers are placed into the final packaging: tray, one piece box, in a ISO5 class with an ISO7 surrounding.

Tyvek® sealing & steribag baggingThe trays are sealed with a Tyvek® lid, packaged in steribags and case-pack allowing for sterilization in a ISO5 class with an ISO7 surrounding. Key attention is given to the cleanliness of the packaging components. Final configuration includes packaging in pallets.

SterilizationSterilization is made through EtO and a process validated according the ISO11135.

Incoming material DepyrogenationSiliconization Closure assemblyWashing SterilizationTyvek sealing & steribag bagging

Nesting and tub insertion/tray

loading

Incoming material DepyrogenationSiliconization Closure assemblyWashing SterilizationTyvek sealing & steribag bagging

Nesting and tub insertion/tray

loading

Incoming material DepyrogenationSiliconization Closure assemblyWashing SterilizationTyvek sealing & steribag bagging

Nesting and tub insertion/tray

loading

Incoming material DepyrogenationSiliconization Closure assemblyWashing SterilizationTyvek sealing & steribag bagging

Nesting and tub insertion/tray

loading

Incoming material DepyrogenationSiliconization Closure assemblyWashing SterilizationTyvek sealing & steribag bagging

Nesting and tub insertion/tray

loading

Incoming material DepyrogenationSiliconization Closure assemblyWashing SterilizationTyvek sealing & steribag bagging

Nesting and tub insertion/tray

loading

SGD Pharma high quality molded vials range

SGD Pharma - 14 bis terrasse Bellini - 92807 Puteaux Cedex - France Tel.: +33 1 40 90 36 00 - Fax: +33 1 40 90 36 51For more information, please contact your local representative

featuring

www.ez-fill.com www.sgd-pharma.com

All vials provided in ISO 20mm neck finish.For other vial type, please contact your local representative.

Standard Upside - Down

Vials configuration

01/2

018

- Des

ign:

- P

hoto

cre

dit:

SG

D -

Prin

ted

in F

ranc

e - P

EFC

Cer

tified

Nominal capacity (ml) Height (mm) Diameter (mm) Status

20 56 30 Under technical validation

25 64.9 30 Available

50 65.5 42.5 Business case in progress100 84.8 52.3

7 40.8 22 Available

50 73 42.5 Business case in progress100 94.5 51.6

ISO Injectables vial

Simply stronger vial