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Bar Sealer Operational Qualification OQ Protocol | Medical Device

SKU: OQ-BAR

$199.00

$199.00

Unavailable

Operational Qualification (OQ) protocol developed for qualifying medical device bar sealing equipment used to seal sterile medical device packaging. Protocol is structured in accordance with FDA process validation guidelines.

• FDA Compliant
• ISO 11607 Compliant
• MS Word Format
• Digital Content - Instant Download

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Bar Sealer Operational Qualification Protocol

​Our Bar Sealer Operational Qualification (OQ) Protocol is used to qualify sterile packaging materials (i.e. Tyvek/Mylar, Foil, PA/PE, Paper/Mylar Pouches) sealed with any make or model bar sealer. The protocol specifies the manufacturing conditions, controls, testing, and expected outcomes. The qualification protocol includes the following elements:

• The manufacturing conditions, including operating parameters, process limits, and raw material inputs.
• The data to be collected and when and how it will be evaluated
• Tests to be performed and acceptance criteria
• Sampling plan, including sampling points, number of samples, frequency of sampling for each operation and attribute. The number of samples provide sufficient statistical confidence of quality both within a batch and between batches.

The Operational Qualification Protocol includes criteria and process performance indicators that allow for a science- and risk-based decision about the ability of the process to consistently produce quality products. The criteria includes:

• A description of the statistical methods to be used in analyzing all collected data
• Provision for addressing deviations from expected conditions and handling of nonconforming data.
• The qualification protocol includes prerequisite requirements in terms of facility design, equipment installation, personnel training and qualification, and verification of materials used in the qualification process and the review and approval of the qualification protocol by appropriate departments.
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To learn more about our Bar Sealer Operational Qualification (OQ) Protocol contact us at info@aplyon.com 
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