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.

Featured Critical Environment Container Categories

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

The application of a dose of radiation in an attempt to destroy all viable forms of life, including bacterial spores. The typical radiation dose required to reach the 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

The application of steam, heat, and pressure in an 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 (e.g., gamma radiation, electron beam), or chemicals (e.g., EtOH, H2O2) to destroy all viable forms of life, including bacterial spores, to an acceptable sterility assurance level (SAL) of 10–6 that has been fully validated. Validation generally includes a statistically significant sampling plan, multiple lots, and the use of validated equipment and processes.

Particulate
cleaning

Water filtered to submicron 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 are then dried and packaged, all in clean-room environments to keep particulates low. Simply being “particulate 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 the use of validated equipment and processes.

Related products and services

Ordering information

Low particulate glassware and plasticware
Depyrogenated glassware
Total organic carbon glassware & water
Silanized Glassware

Bioprocessing resources

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