Zyto-Sterilset®Annex 1 Ready
Sterile packaging for highly specialized users.
When sterility and GMP are required.
Zyto-Sterilset®
We have developed this special packaging for sterile applications in the critical GMP Class A environment (aseptic area).
Applications:
Zyto-Sterilsets® are used in manufacturing facilities and cytostatic pharmacies for patient-specific drugs made from:
- oncology, cytostatic and antibody therapy
- ophthalmology, eye syringe
- parenteral nutrition
- infusion and antibiotic therapy
- and all applications in sterile production
Characteristics:
Zyto-Sterilsets® are sterile and, thanks to their special cascade packaging (Z-Cut®), are suitable for being introduced into the sterile area of GMP class A.
Z-Cut® - Inward transfer according to Annex 1:
The Zyto-Sterilsets® protected by our Z-Cut® packaging system can be safely and GMP-compliantly transported into the sterile area of a sterile workbench (laminar flow workbench) or isolator.
- Annex 1 Ready!
Zyto-Sterilsets®:
- sterile, validated sterile products
- suitable for use within GMP Class A
- Annex 1 Ready
We have developed various packaging systems for the multitude of special applications in the field of sterile production.
Advice:
Please contact us for advice and further information. Our trained staff will be happy to assist you with product selection, application, sterilization, GMP and Annex 1.
Michelle Häfner
Industrial business management assistant
Phone: +49 (0) 6051 494 404-13
E-Mail: m.haefner@kwp-gmbh.de
The sterile protective packaging for your sterile preparation.
Applications:
- for GMP Class-A / Sterile Production
- sterile transport and storage
- cytostatics, antibodies, infusion
The different sizes of the pressure locked bags allow preparations ranging from small-volume ampoules and syringes (e.g. cytostatics, monoclonal antibodies) to large-volume infusions and bags (e.g. parenteral nutrition) to be packaged sterilely and safely.
Characteristics:
KWP Zyto-Sterilset® - DV are:
- a sterile product (DIN EN ISO 11137)
- sizes from 100 ml to 7 l
- practical pressure lock
– optionally with cytostatics warning (according to Workplace Ordinance TRGS 201 & recommendation of the Federal Ministry of Health) - with sterilization indicator and sterilization certificate
- made of extra sturdy foil strong film
- suitable as a packaging system for inward transfer
- packaged in the Z-Cut® system
The sterile protective packaging for the 1 ml (eye) prefilled syringe
Applications:
- sterile transport and re-introduction inward transfer
- secure and comfortable self-adhesive closure
- safe and easy opening due to peelability for removal of the syringe before application
- optionally for single packaging (SST 90-S) or double packaging (SST 90-D) of the syringe
- suitable for the 1, 2, 5 & 10 ml syringe
Inward transfer / SST 90-D:
Double Tyvek® peel packaging ensures safe multiple inward transfers e.g. to the patient or the operating room.
Characteristics:
KWP Zyto-Sterilset® SST are:
- a sterile transport and protective packaging with a practical self-adhesive closure
- sterile, a validated sterile product (DIN EN ISO 11137)
- with sterilization indicator and sterilization certificate
- safe, made of Tyvek® and film
- for single or double packaging of the application
- suitable as a packaging system for inward transfer
- packaged in the Z-Cut® system
Zyto-Sterilset® - SFB
The sterile collection bag with side gusset, for waste containers within GMP Class B.
Applications:
- sterile insert bag for collection containers
- suitable for all areas GMP-Class B
Characteristics:
- sterile, a validated sterile product (DIN EN ISO 11137)
- highly pure, from cleanroom production DIN EN ISO 14644-1, Class 5 / GMP Class B
- large capacity due to side fold
- compact handling and practical storage due to side fold
- extra stable LDPE film
- weldable
- bag-in-bag, double cleanroom packaging
- 40 liter and 70 liter versions available
The precisely fitting, double cleanroom protective packaging made of LDPE film for the infusion syringe.
Applications:
- double transport packaging for the filled 50 ml perfusor syringe (e.g. doxorubicin)
- suitable for all GMP Class B areas
Characteristics:
- highly pure, from cleanroom production DIN EN ISO 14644-1, Class 5 / GMP Class B
- precisely fitting, for the double packaging of e.g. 50ml (doxorubicin) syringe
- optionally sterile
- safe, thanks to extra stable LDPE film
- suitable as a packaging system for re-introduction
- securely closed by welded seam
- safe, through double-packaged transport to the user / patient
Equipment to support your GMP-compliant work in the laminar flow workbench.
Applications:
- hanging stand for collect bags
- application within the sterile workbench GMP-class A
Characteristics:
- stainless steel V2A
- GMP-compliant design
- smooth surface
- no welds, holes, threads
- disinfectable (e.g. IP, surface disinfectant)
- sterilizable (e.g. steam)
German Patent and Trademark Office
Utility Model Protection DE 20 2018 100 442
Security:
- safe loading and unloading through 3-sided access
- high stability
- with leakage safety bowl, autoclavable
- transparent lid with handle, heat-resistant 70°C
Versions:
Capacity 3 liters and 7 liters
Equipment to support your GMP-compliant work in the laminar flow workbench.
© Design protected EUIPO
design protection No. 006587085
Applications:
- ampoule rack for safe handling of up to 15 ampoules
- application within the sterile workbench GMP-Class A
Characteristics:
- suitable for ampoules from 1 ml to 10 ml
- numbered positions
- stainless steel V2A
- GMP-compliant design
- smooth surface
- no welds, holes, threads
- disinfectable (e.g. IP, surface disinfectant)
- sterilizable (e.g. steam)
Security:
- secure position of the ampoules
- numbered positions
- secure assignment
- avoiding confusion
- high stability
Do you need advice on our products?
Please contact us. We look forward to hearing from you.
Contact a consultant