inr_bnr4

We work to stay ahead of the curve, to be an asset to our clients, and to be their satellite knowledge center of expertise and excellence. Below are examples of some of our project work. For more information, contact us.

RETROSPECTIVE VALIDATION

Retrospective validation was performed on a continuous band sealer, a tray sealer and a tray forming and sealing machine used to package medical devices. Retrospective validation using Process Capability Analysis was chosen to quickly assess the risk profile associated with continued use of an existing production operation to determine whether to suspend operations.

GAP ASSESSMENT

Performed a gap analysis to identify the differences between a corporate CoE Packaging Development Standard and a division’s quality system and documented CAPAs to address non-conformities for a medical device company.

TEST METHOD TRAINING

After observing special cause variation in data set, trained manufacturing personnel, who were responsible for in-process quality control testing, on proper techniques to perform seal strength testing using ASTM F-88 for Tyvek pouches and thermoformed trays sealed with Tyvek lidstock.

MEDICAL TRAY SEALER INSTALLATION

Conducted safety assessment on an inherited tray sealer and configured it with safety features to avoid OSHA recordable injuries. Wrote equipment installation qualification protocol and conducted protocol evaluation.

TABLET DAMAGE SOLUTION

Conducted a manufacturing and distribution assessment of prescription sublingual tablet product from point of origin to destination at pharmacies and reviewed production release data; identified reason for product damage and recommended a package design modification that reduced package costs and could be implemented with a minor manufacturing process change.