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Bottle Assemblies

Bottle assemblies are individually configurable plastic bottles, that are equipped with tubing and additional components. These bottles are used for many different processes and allow, for instance, to safely take samples within a completely closed system.

GMPTEC offers you a large variety of different types of bottles which can be used for customized bottle assemblies. Even large-volume carboys can be used without any problems!

Description

Information about Bottle Assemblies

Plastic bottle assemblies are being used in nearly every modern pharmaceutical or biotechnological company.  Some time ago, many customers were still mainly using glass bottles, but now there is a strong trend towards single-use bottle systems made of plastic. Among other reasons, this is due to fact, that the expensive cleaning and sterilization process for glass bottles can be avoided and that it’s possible to design a completely closed and also gamma sterilized system, which can perfectly be fitted to the individual application.

GMPTEC bottle assemblies are designed according to your needs and requirements and can exactly be matched to individual processes and tasks. There are many different options available, which allow to fit the bottle assemblies in nearly every area or process within the company. Especially when it comes to the protection of a high-quality product or the safety of employees, a closed bottle system often is the best choice!

The product portfolio ranges from simple sampling bottles to complex manifold systems, which can be used for drug substance production. No matter if small-scale or production-scale, GMPTEC offers the perfect bottle system for every process!

Of course, we only use excessively tested materials for our bottle assemblies. All assemblies are batch-traceable and you will receive also a certificate of conformance with each delivery. This document reflects certifications like USP Class VI and also FDA compliance.

GMPTEC offers you a broad range of bottles and containers, for example:

  • Standard Bottles
  • Erlenmeyer Flasks
  • Vials
  • Centrifuge Bottles
  • PFA & FEP Bottles
  • Carboys

The available bottle materials range from Polypropylene, Polycarbonate and PETG to high purity fluoropolymers like PFA and also FEP.

The PFA and FEP bottles are a special highlight within the GMPTEC portfolio! They have an enormous temperature resistance, can be used for flash freezing applications with liquid nitrogen, and consist of high-purity fluoropolymer only. These bottles are an absolute innovation when it comes to freezing drug substances and offer an enormous amount of safety, which cannot be archived with alternative solutions.

Processes and Applications

  • Not only Single-Use Assemblies, but also Multi-Use Assemblies
  • Sampling Applications
  • Fill and Finish
  • Buffer Containers
  • Preparation Containers
  • Mixing Bottles
  • Cell Culture
  • Waste-Storage
  • Manifolds
  • Media Fill Assemblies
  • Freezing Applications
  • Bulk Drug Substances

Needless to say, that we can also equip these bottles with tubing and components according to your individual requirements!

An overview of the available bottles and containers and also further information regarding each product can be found in the product category „Bottles and Containers“.

If you are using glass bottles and are searching for a matching bottle top, we also offer individually customized solutions made of silicone. These bottle tops can be equipped with additional components, exactly according to your needs, and are also suitable for multi-use applications!

Bottle Assemblies are compliant to:

  • FDA CFR 21
  • BSE/TSE Statement
  • USP Class VI <88> Biological Reactivity
  • USP Class VI <87> Cytotoxicity
  • USP Class VI <85> Endotoxins
  • Certificate of Conformance
  • Batch Traceable
  • Gamma Resistant
  • Autoclavable
  • ISO Class 7 Cleanroom Manufacturing
  • cGMP Standards
  • Large range of different bottle types and sizes

(Certificates and conformities can vary depending on the choice of materials)

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