Equipment, environment and utilities qualification

We offer a tailor-made consulting service for pharmaceutical companies, APIs, medical devices, biotechnology and pharmaceutical satellite activities.

We deal with instrument calibration, revamping projects, and qualification and re-qualification of equipment, systems and utilities with our own (LAT, SIT, EA) certified scientific instrumentation.

We handle the preparation of the qualification document package through the direct application of Quality Risk Management principles:

Validation Plan
User Requirement Specification and Functional & Design Specification
Risk Assessment and System Impact Assessment
Design Qualification (DQ) and Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols
Periodic re-qualification protocols
Validation report/Summary report

HOW WE WORK

Project team

Our consulting services include the implementation of ,periodic testing of qualification and requalification protocols and of manufacturing equipment, and support in the execution of FAT and SAT during commissioning.

Thanks to our team of Qualification Engineers , we can satisfy the most critical regulatory conditions, ensuring full compliance with international guidelines and GMP standards, particularly those of the FDA and EMA.

PMP-certified project managers supervise the projects, ensuring their completion on-time and on-budget. We monitor the process and constantly update the client, to facilitate co-operation and achievement of the shared goal.

Our twenty years of experience with SMEs in the sector have made us a reliable partner, capable of supporting our customers with high workloads, in preparation for inspections, or for support with skills.

Our experience

Areas and systems that we cover

Production Equipment - Active Pharmaceutical Ingredient

Reactor
Dryer
Centrifuge
Crystalliser
Incubator
Reverse osmosis purification unit
Ultra-filtration purification unit

Production Equipment - Liquid Formulations

Dissolving and filtering unit
Filling line
Flask washer
Depyrogenation tunnel
Autoclave
Oven
Bio-decontamination Unit (VHP)
Component washer
Cold stores
Warehouse

Production Equipment - Solid Formulations

Mixer
Granulator
Tablet press
Coating pan
Filling machine – Encapsulating machine
Blister pack machine

Laboratory and Warehouse Equipment

Autoclave
Component washer
Incubator
Oven
LAF hood and Bio Safety Cabinet
Refrigerator
Ultra Low Temperature Freezer
Stability chamber
Warehouse
Temperature-controlled chamber

Critical Utilities

Systems for the production, distribution and storage of:

Water for Injection
Purified Water
Pure steam
Process gas (compressed air, nitrogen, etc.)

HVAC systems and controlled contamination areas:

Unidirectional Air Flow areas (LAFs)
Environmental monitoring systems (EMS) for critical parameters

Equipment, environment and utilities qualification

Why choose S4BT?

Dedicated team of qualification engineers

Complete document package (ITA-EN) that satisfies the most critical regulatory conditions

Our own (LAT, SIT, EA) certified scientific instrumentation

Customer support during each phase of the system's “Validation Life Cycle”

Projects supervised by PMP-certified project managers

Risk-based approach based on Quality Risk Management principles

An internal network of multidisciplinary skills to optimise the computer system validation strategy

Full compliance with FDA and EMA regulations and guidelines and other specific standards

Our experience

Some of Our Projects

Revamping of the Coating and Blister area

Validation of facility utilities

Thermal Mapping

OUR CUSTOMERS

What they say about us

The work of the S4BT consultants positively influenced the activities they addressed for our company, both with regard to the possibility of comprehensive and complete compliance with FDA observations and in the improvement of maintenance activities in some controlled contaminated areas. I thoroughly enjoyed working with the S4BT consultants and I remain highly satisfied. I would like to work with them again in the future, because they have the right combination of skill, professionalism, flexibility and co-operation. Excellent work on environmental controls and thermal monitoring, as well as on IQ/OQ activities.

CLIENTS