Critical Environment Containers

The only thing in your container is what
you add

Working within a critical environment necessitates high-quality materials, as contamination can quickly spell disaster for what are typically exceedingly
sensitive applications.

How do you select the best containers for your application?

 Container cleanliness is critical. Understanding different cleanliness and validation options, as well as their impact, can help you to identify quality products that will not influence the integrity of your product.

Find out about what you need to consider when selecting a container for your biopharmaceutical manufacturing applications.

Download our infographic ›

Popular critical environment containers

Featured critical environment container categories

Choose from a large range of standard particle-certified containers assembled to contain as few as 5 particles per milliliter > 0.5 microns. Non-standard containers may be custom cleaned on request.

Put your trust in proven products developed by industry experts for performance, usability and cost effectiveness. Glass vials and other containers are offered in a variety of sizes that have been specially prepared to meet endotoxin levels of less than 0.06 EU/mL. 

Total Organic Carbon Certified Containers are certified to contribute <10ppb or < 20ppb TOC as background. Thermo Scientific™ products for Total Organic Carbon (TOC) analysis includes sampling and storage containers, autosampler compatible vials, including the popular 40mL size, and culture tubes. TOC products are manufactured, packaged and tested to exacting standards for use in USP method 643 testing, off-line grab sampling of high purity water and storage of validation standards. A certificate of Analysis is included with each shipment.

Surface deactivation treatments such as silanization may play an important role in preserving the integrity of certain materials or extracts stored in glass containers. It also helps to avoid alkalinization of contents which may occur as carbonates leach from the glass with normal weathering.


Process definitions table

With the capabilities to generate a broad combination of cleanliness parameters and certifications, coupled with custom packaging options, we can meet your precise specifications and requirements.   Download table ›

Process

Definition

Irradiation

Application of a radiation dose in an attempt to destroy all viable forms of life including bacterial spores. A typical radiation dose required to reach a desired Sterility Assurance Level (SAL) of 10-6 is 25-40 kGy. Simply being "irradiated" is not a guarantee of sterility (see "Sterile" below).

Autoclaving

Application of steam, heat and pressure to attempt to destroy all viable forms of life, including bacterial spores. The amount of time, heat and pressure can vary depending upon several factors. Simply being "autoclaved" is not a guarantee of sterility (see "Sterile" below).

Sterile

Sterilization involves the application of steam, heat and pressure (autoclaving), irradiation (gamma, e-beam, etc.) or chemicals (EtOH, H 2O2, etc.) to destroy all viable forms of life, including bacterial spores, to an acceptable sterility assurance level (SAL) of 10-6 which has been fully validated. Validation generally includes a statistically significant sampling plan, multiple lots and use of validated equipment/processes.

Particulate
cleaning

Water filtered to sub-micron levels (USP Water or WFI for example) is used for the particulate cleaning process. Water is heated and used to "wash" items in multiple cycles. Materials would then dried and packaged, all in clean room environments to keep particulates low. Simply being "particle washed" is not a guarantee of sterility (see "USP<788>" below).

USP <788>

Compliance to USP<788> requires that either a product is produced in a clean environment or a product is particulate washed, such that you can achieve a validation of this low particulate limit. Validation generally includes a statistically significant sampling plan, multiple lots and use of validated equipment/processes.