Disposables

Disposable Bioprocessing Systems

BIOEAZE® single-use systems offer a wide range of catalog products as well as the ability to make custom bags, bioreactor kits, sample, rigging and tubing sets as needed to meet client’s requirements. Catalog product is off-the-shelf and ready to go, or we can design and supply custom systems with the fastest turnaround time in the market.

Product Details:
	cGMP manufactured, ISO Class 13485 in a class 10,000 certified clean room
	Class VI bag films, components for incorporation into designs as selected
	Bags from 50 mL to 2,000 L, Polyethylene (PE) and Ethyl Vinyl Acetate (EVA) films
	Bag assemblies, rigging sets, filter sets, components, tank liners, tubing, storage and transport
	Custom systems designed to your specifications
	Technical knowledge, expertise and support when you need it

Benefits:
There are real benefits associated with BIOEAZE® single-use systems.
	Safety – management of contamination risk
	Speed – reduction and management of lead times
	Scaleable – bags and films from 50 mL to 2,000 L
	Cost management – supports facilities’ growth strategy, as single-use systems replace stainless steel and glass
	Time efficiency – systems are provided assembled and sterile
	Versatility and innovation – BIOEAZE® is completely customized to fit your process and enhance your operations
	Success – BIOEAZE® is currently used in the manufacture of approved pharmaceutical products
	Minimizes cleaning validation
	Plays to rapid scale-up and scale-back
	Saves space

System Design
BIOEAZE® bioprocessing systems can be designed for your specific facility and liquid handling needs. By contacting your Business Development Manager or Customer Service Representative, you have direct access to our BioProcess Engineers (BPE). Once a request is made, our BPE group can either work with a drawing you have provided or design a system around your exact needs. To ensure that your specifications are met, all final drawings require your final sign-off and approval before manufacture.

Design Process
	Consultation with BPE
	SAFC Biosciences drawing developed
	Customer drawing reviewed, revised and signoff
	Specification developed, reviewed and signoff
	SAFC Biosciences drawing developed
	Package complete and ready to be ordered

Testing and Technical Support
SAFC Biosciences provides a wide range of testing and validations, which will support you throughout the entire development and manufacturing process.

Our single-use bioprocessing systems are tested to stringent specifications to ensure that our customers are supplied with the highest quality products possible.

For details on testing and technical information please click on the Related Files link. Documents in this section include, but are not limited to:

	Film Information
	Testing Biological – USP Class VI, Endotoxin Physical – Structure, Permeability Functional – Irradiation Validation, Shipping integrity In-Process – Raw Materials and Manufacturing Inspections
	Technical Bulletins
	Definitions
A detailed validation binder is available upon request.