The CRL Single-Use Beta Bag is a safe, efficient, and cost-effective solution for transfer of components into isolation or
removal of toxic components out of isolation.
Used in assembly with Alpha port systems, to maintain the sealed containment & sterility of the environment.

The Single-Use Beta Bag system consists of Tyvek® and high-density polyethylene (HDPE) bag layers connected to a Beta flange
which fits to the Alpha port on an isolator.
Once filled with components, these bags can be autoclaved and connected for filling line production.

Bag customization is also available to meet specific application needs based on component, processing, and production parameters.

In addition to its proprietary design, CRL has also developed a Single-Use Beta Bag flange is compatible with other designs of Alpha
port designs. This allows more flexibility with additional beta bag options available at their disposal.

Specifications:

MATERIALS:
Flange and Cover: High Temperature Polycarbonate
Beta Seal: FDA Approved Silicone
O-Ring: FDA Approved Silicone
Weld Ring: HDPE
Bag: Tyvek® (1073B) and HDPE

CLEANLINESS:
Particulate: USP<788>
Endotoxin: < 0.125 EU / mL

STERILIZATION METHOD:
Autoclave or gamma sterilizable

ENVIRONMENT:
Assembly is designed to be steam sterilized at 121°C for 30 minutes by the customer.
Recommended storage conditions are 55-80°F (13-27°C) and 30-60% Relative Humidity.

BAG DIMENSIONS:
Flange Diameter: 190 mm
25” (635mm) length, useable
16.5” (419mm) width, useable
Approximate volume of 25 L

ASSEMBLY:
Assembled in an ISO cleanroom

PACKAGING:
Product double bagged with polyethylene cleanroom bag.

STANADARD DOCUMENTATION:
- COA for Material of Construction
- COC for the product
- Dimensional Inspection Results (Components)
- Dimensional Inspection Results (Assembly)
- Weld, Peel & Dye Test Results for Tyvek Bag
- Weld, Peel & Dye Test Results for End Weld & Port Weld
- Assembly Record with Traceability to Batch Lots
- Lab Test Results for Particulate & Endotoxin