Bottle Assemblies
Brand: GMPTec
Our Bottle Assemblies feature a versatile selection of bottles, flasks, and tubes that can be fully customized, including large-volume carboys. Each assembly is tailored with plastic bottles, tubing, and additional components, designed to support various processes and ensure safe sampling within fully closed systems.
Features
Benefits
- Customizable bottle assemblies for specific processes.
- Range spans from simple sampling bottles to complex manifold systems for small- and large-scale production.
- Closed systems ensure product integrity and employee safety.
- Batch-traceable with USP Class VI and FDA compliance.
- Sterilizable by gamma irradiation and high pressure saturated steam.
- Produced in an ISO Class 7 cleanroom under cGMP standards.
Applications
- Sampling
- Filling and finishing
- Buffers
- Preparation
- Mixing
- Cell culture
- Waste storage
- Manifolds
- Media fill
- Freezing
- Bulk drug substances
Types of Containers
- Standard bottles
- Erlenmeyer flasks
- Vials
- Centrifuge bottles
- PFA, ETFE & FEP bottles
- Carboys
Specifications
| Sterilization Methods | : | Gamma irradiation |
| : | High-pressure saturated steam | |
| Container Materials | : | PP (polypropylene) |
| : | PC (polycarbonate) | |
| : | PETG (polyethylene terephthalate glycol) | |
| : | PFA (perfluoroalkoxy) | |
| : | ETFE (ethylene tetrafluoroethylene) | |
| : | FEP (fluorinated ethylene propylene) |
Compliance
- FDA CFR 21
- USP Class VI <88> (Biological reactivity)
- USP Class VI <87> (Cytotoxicity)
- USP <85> (Endotoxin testing)
- BSE/TSE Certification
Note: Certificates and compliance may vary depending on the materials selected.