ILC Dover - Flexible Powder Containment Technologies

ILC Dover offers flexible powder containment technologies, eliminating many of the problems associated with the use of traditional metal and glass systems for the pharmaceutical industry. The company applies flexible solutions to pharmaceutical potent powder containment during processing of bulk compounds and oral solid dosage manufacturing throughout the industry from North America to Europe and Asia.

As demonstrated by the Risk-MaPP principles, both current good manufacturing practices (cGMP) and industrial hygiene (IH) needs can be met by containing the process at the source. By employing flexible containment and using the logic diagrams from the Risk-MaPP process, cleaning is minimized and the operator is protected with this engineering control. As such, processes in multi-product facilities can be safely performed without the risk of cross contamination.

DoverPac® flexible containment technologies offer:

• Protection from potent compounds
• cGMP for API and bulk manufacturers
• Low capital costs
• Rapid turnkey solutions
• No risk of cross contamination in multi-process and dedicated facilities
• Lowest cost of processing

Containment services for bulk compound processing

DoverPac® has gained wide acceptance by the pharmaceutical industry for use during processing of bulk compounds. DoverPac® prevents worker exposure to highly potent compounds and can eliminate the need for protective garments and respirators.

Continuous contained powder processing

ILC Dover's flexible containment technologies allow continuous, contained processing utilizing ArmorFlex™ films developed specifically for the pharmaceutical industry. DoverPac® fabrication techniques are based on over 50 years of experience in life-critical product manufacturing.

Containment for potent compounds

Unlike standard flexible intermediate bulk containers that are not designed specifically for potent compound manufacturing, DoverPac® is designed to assist operators in performing operations without ever opening up the system. And, our ISO: 9001 registration assures product quality and operator safety during pharmaceutical potent powder containment operations.

FDA and EU compliant

ILC’s innovative ArmorFlex containment material is compliant with FDA and EU requirements:

• Complies with FDA 21 CFR
• Meets 2002 / 72 / EC requirements
• Passes USP 661 physicochemical tests for plastics
• Passes USP 88 class VI (7 day implant)

Validated processes

Flexible containment is a validated process that utilizes quality engineered products designed to meet critical requirements for:

• Five year shelf-life
• Permanent antistant replaces migrating additives
• No animal derived components
• Passes chilworth incendivity tests
• DMF filed with FDA

Upgrade existing facilities for potent compound containment

DoverPac® is one of the fastest growing containment solutions in the industry. Our worldwide clients have appreciated the ability to upgrade existing facilities for potent compound containment during processing. This ability to upgrade has allowed our clients to avoid the capital expense of new equipment and / or facility upgrades. And, the fast turn around to facility upgrading for pharmaceutical containment has meant significant decreases in facility start-up times.