Single-Use RTP Beta Bag Single-Use Beta Bag

Beta Bag 190mm: Secure and Compliant Material Transfer

I. Sterile Transfer Bags for Contamination-Free Pharmaceutical Production

DeltaQuant Single-Use Beta Bags with a 190 mm port are advanced single-use transfer bags for the pharmaceutical industry, designed for safe, rapid, and contamination-free transfer of sterile components into isolators, as well as for the removal of aseptic waste from filling lines.

These single-use bags allow sterile items such as rubber stoppers, caps, and other bio/pharmaceutical production materials to be maintained in a sterile condition and easily introduced into production equipment through the Rapid Transfer Port (RTP) installed in isolators and RABS (Restricted Access Barrier Systems). The system enables pharmaceutical and biotechnology facilities to transfer equipment, sterile components, and powder transfer into and out of isolators, glove boxes, and cleanrooms without compromising sterility.

As a reliable single-use beta bag manufacturer and supplier, DeltaQuant Lifesciences delivers high-performance sterile transport solutions designed for modern pharmaceutical and biotechnology manufacturing environments.

  • Contamination-Free Transfer
  • Single-Use Validated System
  • Steam and Gamma Sterilization Compatible
  • Multi-Connect Capability

II. Benefits of Using Single-Use Beta Bags (RTP Beta Bags)

  1. 1. Maintains Sterility Single-use beta bags keep materials isolated from the external environment, helping maintain sterility during transfers between isolators and cleanroom systems.
  2. 2. Prevents Cross-Contamination They reduce the risk of contamination when transferring powders, sterile components, or sensitive pharmaceutical materials.
  3. 3. Improves Safety for Operators The closed transfer system protects operators from exposure to potent or hazardous substances.
  4. 4. Reduces Validation Effort Eliminates the need for complex cleaning validation processes required for reusable transfer containers.
  5. 5. Faster and Efficient Material Transfer The docking mechanism (such as twist-and-lock RTP systems) allows quick and secure connection between isolators.
  6. 6. Cost-Effective Operations By reducing cleaning, maintenance, and downtime, single-use systems can lower overall operational costs.

III. Technical Specifications (For Pharma Use)

Specification Detail Importance in Pharma
Collar Diameter 190 mm (DN190) Ensures secure, leak-tight docking with Alpha Ports used in RTP beta bags systems.
Film Material Low-Density Polyethylene (LDPE) or a custom blend Provides durability, low particulate generation, and chemical resistance for pharma-grade bags.
Sterilization Gamma Irradiation (typically 25 kGy minimum) Ensures sterile transport bags are ready for use in Grade A/B pharmaceutical environments.
Certifications Certificate of Conformity (CoC) and Certificate of Irradiation (CoI) Supports traceability, regulatory audits, and compliance with the pharmaceutical beta bags manufacturer standards.

Key Advantage

Engineered for performance, designed for compliance

1

Contamination-Free

Double-layer Tyvek®/HDPE construction ensures complete barrier integrity during aseptic transfer operations.

2

Dual Sterilization

Available in Gamma Sterile (ready-to-use) and Autoclavable variants for maximum operational flexibility.

3

Validated Performance

Rigorously tested seal strength, leak tightness, and cleanliness per USP, ASTM, and ISO standards.

4

Universal Compatibility

190 mm beta port fits standard alpha port systems. Multi-connect rated for up to 5 docking cycles.

5

Pharma-Grade Materials

All contact materials meet USP Class VI biocompatibility and FDA 21 CFR compliance requirements.

6

Reduced Operational Cost

Single-use design eliminates cleaning validation. No decontamination required between transfers.

Product Specifications

Engineered for diverse aseptic manufacturing needs

Specification
10L Double Bag
25L Double Bag
Beta Port Diameter
190 mm
190 mm
Useful Volume
10 L
25 L
Configuration
Double Bag
Double Bag
Sterilization
Gamma / Autoclave
Gamma / Autoclave
Autoclave Parameters
121°C for 30 min, 1 cycle
121°C for 30 min, 1 cycle
Max Weight Load
5 kg
7 kg
Bag Films
Tyvek® 1073B + HDPE
Tyvek® 1073B + HDPE
Flange & Door
High Temp. Polycarbonate
High Temp. Polycarbonate
Seal & O-Ring
FDA Approved Silicone
FDA Approved Silicone
Weld Ring
HDPE
HDPE
Multi-Connect
Up to 5 dockings
Up to 5 dockings
Shelf Life
5 years from manufacture
5 years from manufacture

Cleanliness & Biocompatibility

  • Bioburden Level: < 1000 cfu/bag as per ISO 11737-1
  • Bacterial Endotoxin: < 0.125 EU/mL (LAL test per USP <85>)
  • Particulate: ≥ 10 µm: NMT 20 #/mL | ≥ 25 µm: NMT 3 #/mL
  • Fiber Release: Compliant with USFDA Title 21 CFR Part 210.3(b)(6)
  • Biocompatibility: USP Class VI | ISO 10993

Regulatory Compliance

  • USP Class VI Biocompatibility: All contact materials tested per USP <88>
  • FDA 21 CFR 177.1520: HDPE and Tyvek® film compliance
  • FDA 21 CFR 177.2600: Silicone seal compliance
  • ISO 10993 Biocompatibility: Polycarbonate components
  • BSE/TSE Compliance: EMEA 410/01 certified materials
  • Ph. Eur. 3.1.5: European Pharmacopoeia compliance
  • Cleanroom Manufacturing: Bag manufactured in ISO Class 4-5 cleanroom

Materials of Construction

Component Material
Beta Flange & Door High Temperature Polycarbonate
Beta Seal FDA Approved Silicone (USP Class VI)
O-Ring FDA Approved Silicone
Weld Ring HDPE (Marlex Natural)
Bag – Top Layer HDPE Film
Bag – Bottom Layer DuPont Tyvek® 1073B
Protective Cover Polycarbonate
Clamp Collar Polycarbonate