sterile ready-to-fill molded vials pharma_sterile-ready-to... · 2020. 9. 4. · it is the perfect...
TRANSCRIPT
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