Process, Packaging & Cleaning Validation

We offer an innovative outsourcing service providing Process, Packaging & Cleaning Validation activities for pharmaceutical companies.

The service includes:

A team with a variable structure (in terms of number and seniority) according to the client’s needs
A Senior Consultant Project Manager, with several years of experience in the field, leading the team
A proprietary digital tool for enteringrequests, monitoring the assigned activities and project reporting.

The service can be customised by the client, who can also request the support of individual resources according to their needs.

VALIDATION SERVICE

Activity Details

Drafting of protocols and reports
Activities in the field (shop floor)
Sampling
Supervision of manufacturing, packaging and cleaning processes for the execution of protocols
Statistical processing of analytical and process data for the drafting of reports
Process and Cleaning Validation impact assessment for the introduction of new products and equipment and revamping of production areas
Validation Master Plan updating and subsequent coordination of the validation activities
Updating of cleaning procedures (Cleaning Validation)
Drafting of Master Batch Records for pre-validation and validation batches
Review of the process forms and of the batch records for pre-validation and validation batches

success stories

Results obtained in just one year
by one of our clients

Protocols

Reports

Evaluations

Sampling

Shifts

our expertise

Some of Our Projects

Hold Time Validation of Manufacturing Intermediates for Tablets

Process Deviation Management, Change Control, CAPA

Validation of analytical methods for EHS departments

BENEFITS

Why choose the S4BT Validation Service?

You save on labour costs and resource training as well as on infrastructure

You increase efficiency thanks to the expertise and support of experienced and qualified specialists

You can focus on the core business and regain capacity

The risk is borne by the supplier

You can monitor activities in real time with a digitised workflow and extract useful data and reports

You can customise the service with a team of variable composition and a Project Manager always present

Total shift coverage 24/7, 365 days a year, on request. So you never stop production

Internal network of multidisciplinary skills for an integrated approach, with the qualification of plant, systems and utilities

OUR CUSTOMERS

What they say about us

We have been co-operating for years with S4BT consultants because of their availability, experience and in-depth knowledge of pharmaceutical production processes and international regulations in the Cleaning & Process Validation field.

CLIENTS