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Here are a few examples of how Oliver-Tolas OnSite is helping medical device manufacturers (MDMs) meet their package engineering goals. How can we help you? Contact us today to find out.
Ensuring regulatory compliance
A small MDM wants to ensure regulatory compliance of its sterile barrier system and process validation for pouches. Oliver-Tolas OnSite writes ISO 11607-compliant OQ, PQ, simulated distribution, and package stability protocols and supervises material and machinery validation trials. The MDM's practices are updated to current industry standards, thanks to the expertise of Oliver-Tolas OnSite packaging engineers.
Upgrading packaging configuration validation processes
A surgical device manufacturer feels its sterile package validation approach is outdated. Oliver-Tolas OnSite develops ISO-compliant OQ and PQ process validation and sterile barrier system protocols. The manufacturer is able to expedite the needed protocol upgrade and use in-house resources to complete its validation runs on schedule, saving time and money.
Material conversion at a small MDM
A small MDM without package engineering staff would like to convert to lower-cost materials but lacks the resources and expertise to make the change. Oliver-Tolas OnSite provides full project management at the customer facility, including assistance with validation and adherence to ISO 11607 guidelines. The MDM projects significant annual cost savings due to the change.
Identification of cost savings opportunities
The packaging engineering department of a large MDM is feeling the pressure from management to reduce costs. The customer has special puncture resistance and shipping requirements to consider as well. Oliver-Tolas OnSite conducts an analysis of the customer's current materials and processes and develops a new material that meets the customer's special requirements.
Material conversion for large MDM
A large MDM with a fully staffed engineering department is interested in converting to lower-cost materials. Oliver-Tolas OnSite works alongside the customer's engineer as an additional resource and provides assistance with protocol development, stability testing, and technical troubleshooting. The timeline to implementation is shortened and fewer customer resources are required to complete the project.
Thermo form/fill/seal material conversion at a medium-sized MDM
A medium-size MDM would like to convert materials on one of their thermo form/fill/seal lines. The MDM's packaging engineering staff lacks experience with this particular technology and machinery, while Oliver-Tolas OnSite package engineers have extensive experience working at an MDM on thermo form/fill/seal processes. OnSite works directly with the customer's corporate engineering staff, as well as the manufacturing facility, to successfully make the change.
ISO 11607 compliance
A large MDM's engineering staff is stretched too thin to take on the task of navigating the newest ISO standards. Oliver-Tolas OnSite provides the team with expert support in ensuring ISO standards are met.
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