Single-Use Beta Bag Single-Use RTP 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.

application

Where DeltaQuant Beta Bags Work

1

Aseptic Drug Product Manufacturing

Primary sterilized product transfer into filling isolators for injectable drugs, biologics, and ophthalmic formulations.

2

Sterile API Powder Transfer

Controlled transfer of active pharmaceutical ingredients where contamination or potency loss would be critical.

3

Lyophilization Tray Transfers

Loading and unloading freeze-drying trays while maintaining the sterile boundary from fill to lyophilizer.

4

Vial, Syringe & Stopper Loading

Component loading into filling lines without breaking isolator integrity — one of the highest-risk transfer points in sterile filling.

5

Aseptic Waste Removal

Safe removal of waste from the isolator environment — rejects, used materials, and packaging — without contaminating the surrounding cleanroom.

6

Sterile Component Transfer into Isolators

Introducing rubber components, glass parts, metal closures, and other pre-sterilized items directly into the controlled zone.

7

Cleanroom Material Staging

Staging and pre-positioning materials in controlled environments ahead of production runs to reduce mid-batch transfers.

8

Sampling & Environmental Monitoring

Bringing sampling tools, media plates, and monitoring equipment into the isolator and removing filled samples without compromising asepsis.

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