GxP Decontamination To FDA MHRA EMA
GxP Decontamination To FDA MHRA EMA
GxP Decontamination To FDA MHRA EMA
Validation Consultancy Services By A ZES Experienced Consultant
Validation Consultancy Services By A ZES Experienced Consultant
Decontamination
Autoclaves, Washers, Heat Tunnels, etc
Decontamination of pharmaceutical products or medical devices is a very specialised area. The validation of steam autoclaves to achieve a 10^6 reduction of viable spores is an activity a Zener Engineering Services Ltd (ZES) Validation Consultant
can undertake. Activities such as hands-on maintenance, calibration and thermal mapping,
are all part of the team's experience.
ZES have helped to design new decontamination facilities, including utilities and process flows. Compliance with the relevant FDA / MHRA / EMA / HTM / EN regulatory requirement is paramount. Autoclaves, Washers and Heat Tunnels our team have experience with, include:
| Fedegari | Getinge | SAL | Finn Aqua |
| Lytzen | Steris | Hamo | Bosch |
Decontamination
Autoclaves, Washers, Heat Tunnels, etc
Decontamination of pharmaceutical products or medical devices is a very specialised area. The validation of steam autoclaves to achieve a 10^6 reduction of viable spores is an activity a Zener Engineering Services Ltd (ZES) Validation Consultant
can undertake. Activities such as hands-on maintenance, calibration and thermal mapping, are all part of the team's experience.
ZES have helped to design new decontamination facilities, including utilities and process flows. Compliance with the relevant FDA / MHRA / EMA / HTM / EN regulatory requirement is paramount. Autoclaves, Washers and Heat Tunnels our team have experience with, include:
| Fedegari | Getinge | SAL | Finn Aqua |
| Lytzen | Steris | Hamo | Bosch |
Decontamination
Autoclaves, Washers, Heat Tunnels, etc
Decontamination of pharmaceutical products or medical devices is a very specialised area. The validation of steam autoclaves to achieve a 10^6 reduction of viable spores is an activity a Zener Engineering Services Ltd (ZES) Validation Consultant
can undertake. Activities such as hands-on maintenance, calibration and thermal mapping, are all part of the team's experience.
ZES have helped to design new decontamination facilities, including utilities and process flows. Compliance with the relevant FDA / MHRA / EMA / HTM / EN regulatory requirement is paramount. Autoclaves, Washers and Heat Tunnels our team have experience with, include:
| Fedegari | Getinge | SAL | Finn Aqua |
| Lytzen | Steris | Hamo | Bosch |
"ZES are superb in delivering a great service."
Peter West
Head of Quality Affairs at ECLEVAR
Cost Effective Strategy Implementation By ZES
The basis of a cost effective decontamination strategy is the provision of sterile products or medical devices to satisfy the clinical need. There are many factors to be considered to achieve production line efficiencies and cost effectiveness, including
- Training
- Operational Times
- Process Technologies
- Customer Perceptions
- Management Structure
- Plant Flexibility, Capacity, etc
- Facility Size and Restrictions
- Quality and Frequency of Maintenance (Down time)
- Capital Cost (and depreciation) with Running Costs vs Outsourcing
- Scheduling / Operation of Machines (Overall Equipment Effectiveness)
Would you like an efficient decontamination operation
and believe improvements can be found?
Call the experts, call ZES.
"ZES are superb in delivering a great service."
Peter West
Head of Quality Affairs at ECLEVAR
Cost Effective Strategy Implementation By ZES
The basis of a cost effective decontamination strategy is the provision of sterile products or medical devices to satisfy the clinical need. There are many factors to be considered to achieve production line efficiencies and cost effectiveness, including
- Training
- Operational Times
- Process Technologies
- Customer Perceptions
- Management Structure
- Plant Flexibility, Capacity, etc
- Facility Size and Restrictions
- Quality and Frequency of Maintenance (Down time)
- Capital Cost (and depreciation) with Running Costs vs Outsourcing
- Scheduling / Operation of Machines (Overall Equipment Effectiveness)
Would you like an efficient decontamination operation
and believe improvements can be found?
Call the experts, call ZES.
"ZES are superb in delivering
a great service."
Peter West
Head of Quality Affairs at ECLEVAR
Cost Effective Strategy Implementation By ZES
The basis of a cost effective decontamination strategy is the provision of sterile products or medical devices to satisfy the clinical need. There are many factors to be considered to achieve production line efficiencies and cost effectiveness, including
- Training
- Operational Times
- Process Technologies
- Customer Perceptions
- Management Structure
- Plant Flexibility, Capacity, etc
- Facility Size and Restrictions
- Quality and Frequency of Maintenance (Down time)
- Capital Cost (and depreciation) with Running Costs vs Outsourcing
- Scheduling / Operation of Machines (Overall Equipment Effectiveness)
Would you like an efficient decontamination operation
and believe improvements can be found?
Call the experts, call ZES.
Decontamination Experienced Consultancy From ZES
Our industry experience, where cost effectiveness in operations is part and parcel of everyday departmental design and organisational structure, can significantly improve your cost base by utilising our streamlining approaches, proven by many blue chip companies.
Most of our consultant engineers have hands-on experience of maintaining / operating autoclaves from early in their careers, which provides a fundamental knowledge and sound basis for ensuring the clinical need is met efficiently and effectively and forms a sound foundation for making more senior efficiency operational decisions, through time and motion studies if required.
Our Director's Master's Degree covered Manufacturing Operations and Improvement and, having performed such tasks in industry and the NHS many times, can speak with authority on this subject. David Easton has helped NHS departments to save money by adopting streamlined risk-based approaches, where patient risk was a significant factor.
Concerned about dirty little secrets?
Decontamination Experienced Consultancy From ZES
Our industry experience, where cost effectiveness in operations is part and parcel of everyday departmental design and organisational structure, can significantly improve your cost base by utilising our streamlining approaches, proven by many blue chip companies.
Most of our consultant engineers have hands-on experience of maintaining / operating autoclaves from early in their careers, which provides a fundamental knowledge and sound basis for ensuring the clinical need is met efficiently and effectively and forms a sound foundation for making more senior efficiency operational decisions, through time and motion studies if required.
Our Director's Master's Degree covered Manufacturing Operations and Improvement and, having performed such tasks in industry and the NHS many times, can speak with authority on this subject. David Easton has helped NHS departments to save money by adopting streamlined risk-based approaches, where patient risk was a significant factor.
Concerned about dirty little secrets?
Decontamination Experienced Consultancy From ZES
Our industry experience, where cost effectiveness in operations is part and parcel of everyday departmental design and organisational structure, can significantly improve your cost base by utilising our streamlining approaches, proven by many blue chip companies.
Most of our consultant engineers have hands-on experience of maintaining / operating autoclaves from early in their careers, which provides a fundamental knowledge and sound basis for ensuring the clinical need is met efficiently and effectively and forms a sound foundation for making more senior efficiency operational decisions, through time and motion studies if required.
Our Director's Master's Degree covered Manufacturing Operations and Improvement and, having performed such tasks in industry and the NHS many times, can speak with authority on this subject. David Easton has helped NHS departments to save money by adopting streamlined risk-based approaches, where patient risk was a significant factor.
Concerned about dirty little secrets?
Don’t just
take our word for it...
Sterile MD Manufacturing Facility: Decontamination Strategy
"The project was the installation of a Class III, Sterile Medical Device manufacturing line.
(56m Euro)
During the course of the project, ZES showed considerable knowledge on a wide variety of engineering functions and were a key member in the design process of the facility and manufacturing equipment.
...... ZES showed considerable knowledge on engineering and validation."
QC/RA Specialist
BD Medical
Testimonials From Various Satisfied GxP Clients
SSD LIMITED
Don’t just take our word for it...
AE Services: Theatre Sterile Supply Unit
"Interacting with Zener Engineering Services was a education. Its a scarce event that we get to meet those willing to share their knowledge - Its even rarer to encounter an organisation with such a wide range of experience on tap."
(Google Review *****)
Garth Rowbottom
Director
Sterile Service Developments Ltd
Don’t just take our word for it...
Sterile MD Manufacturing Facility: Decontamination Strategy
"The project was the installation of a Class III, Sterile Medical Device manufacturing line.
(56m Euro)
During the course of the project, ZES showed considerable knowledge on a wide variety of engineering functions and were a key member in the design process of the facility and manufacturing equipment.
...... ZES showed considerable knowledge on engineering and validation."
QC/RA Specialist
BD Medical
Don’t just take our word for it...
Sterile MD Manufacturing Facility: Decontamination Strategy
"The project was the installation of a Class III, Sterile Medical Device manufacturing line.
(56m Euro)
During the course of the project, ZES showed considerable knowledge on a wide variety of engineering functions and were a key member in the design process of the facility and manufacturing equipment.
...... ZES showed considerable knowledge on engineering and validation."
QC/RA Specialist
BD Medical
Your Decontamination Experienced GMP Engineering Consultant
Recently ZES reviewed a high profile
NHS decontamination facility.
Significant opportunities for compliance improvement
were identified and engineering solutions provided.
Contact ZES for all your decontamination expertise.
Your Decontamination Experienced GMP Engineering Consultant
Recently ZES reviewed a high profil NHS decontamination facility.
Significant opportunities for compliance improvement were identified and engineering solutions provided.
Contact ZES for all your decontamination expertise.
Your Decontamination Engineering Consultant
Recently ZES reviewed a high profile
NHS decontamination facility.
Significant opportunities for compliance
improvement were identified
and engineering solutions provided.
Contact ZES for all your
decontamination expertise.
