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Dose Establishment Studies

Establishing the Dose Your Product Requires

Dose establishment studies support the evaluation of the radiation dose required to achieve the intended processing objective while considering the product's response to irradiation.

DOSE WINDOW EVALUATION
EVALUATION
LOWER DOSE HIGHER DOSE
MIN Required Effect
MAX Product Acceptance
THE STUDY OBJECTIVE

Evaluating the Appropriate Dose Range

Supporting the development of irradiation conditions that address the intended processing objective and product requirements.

PROCESS OBJECTIVE What must be achieved?
DOSE EVALUATION What dose is required?
PRODUCT RESPONSE How does the product respond?
The Dose Establishment Pathway

Why Dose Establishment Comes Before Process Validation

Before a repeatable irradiation process can be validated, the dose required to achieve the intended processing objective must first be evaluated in relation to the product and its requirements.

STEP 01

Processing Objective

Define what the irradiation process is intended to achieve for the product or application.

STEP 02

Product Studies

Evaluate the product under defined irradiation conditions and study its response.

STEP 03

Dose Evaluation

Evaluate dose information in relation to the processing objective and product requirements.

STEP 04

Established Dose

Define the dose requirement or dose range appropriate to the intended irradiation application.

STEP 05

Mapping & Validation

The established dose requirement supports subsequent dose mapping and process validation activities.

DOSE ESTABLISHMENT ASKS

What Dose Does the Product Require?

The study evaluates the irradiation dose in relation to the intended processing objective and product response.

DOSE MAPPING ASKS

How Is That Dose Distributed?

Dose mapping evaluates absorbed dose distribution throughout the defined product loading configuration.

Establish the Dose. Then Validate the Process.

Dose establishment and dose mapping address different technical questions, but together they support the development of a defined irradiation process.

When Is It Required?

When Should You Consider a Dose Establishment Study?

Dose establishment may be considered when the irradiation requirement, product, application or processing objective has not yet been adequately defined or requires further technical evaluation.

01

New Product Introduction

When a product is being introduced into an irradiation process and the applicable dose requirement needs to be evaluated.

02

New Irradiation Application

When gamma irradiation is being evaluated for a new technical, quality or processing objective.

03

Product Changes

When changes to product composition, characteristics or other relevant factors may affect the irradiation requirement.

04

Processing Objective Changes

When the intended outcome of irradiation changes and the applicable dose requirement requires evaluation.

05

Quality & Technical Requirements

When applicable quality, validation or technical requirements call for documented evaluation of the irradiation dose.

06

Research & Development Studies

When irradiation studies are required to explore product response, technical feasibility or potential applications.

Not Every Product Begins with a Defined Irradiation Dose.

Dose establishment studies provide a structured pathway for evaluating the relationship between the processing objective, irradiation dose and product response.

Working With VAPL

Dose Establishment Studies at VAPL

VAPL works with manufacturers and product developers to support structured irradiation studies based on the product, intended application and study objective.

STEP 01

Understand the Requirement

Discuss the product, irradiation application and intended processing objective.

STEP 02

Define the Study Objective

Establish what the irradiation study is intended to evaluate or demonstrate.

STEP 03

Conduct the Irradiation Study

Products are irradiated according to the defined study approach and requirements.

STEP 04

Evaluate Study Results

Dose information and relevant product study results are evaluated against the study objective.

STEP 05

Study Documentation

Applicable study information and results support subsequent technical and processing decisions.

THE STUDY OUTCOME

Supporting the Next Stage of Irradiation Process Development

The information generated through the study can support evaluation of the applicable irradiation dose requirement and progression towards subsequent process development, dose mapping or validation activities.

Planning a Dose Establishment Study?

Discuss your product, irradiation application or study objective with the VAPL team.

Discuss Your Requirement →

Vishvesh Agromed Private Limited (VAPL) is a strategic sterilisation partner providing Contract Sterilisation Services, Dose Mapping & Validation, Dose Establishment Studies, and Radiation Dosimetry Services for medical devices, pharmaceuticals, packaging materials, food products and industrial applications.

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© 2023 Vishvesh Agromed Pvt. Ltd. All Rights Reserved. 
Designed By
Anubandhaka

© 2023 Vishvesh. All Rights Reserved. 
Designed By
Anubandhaka