From meeting regulatory requirement to customising essential approaches to streamlining manufacturing operations, our consultancy services ensure the highest quality cleanrooms and facilities for our clients in the medical, healthcare, pharmaceutical, biotechnology, food and beverage, research laboratory and manufacturing industries. We also provide support to ensure these utilities and equipment perform as intended.
Cleanroom designs and build services are 3P TECH’s specialization and are handled by a dedicated team of engineers, process engineers, quality assurance specialists and installers, all of whom are committed to quality and customer service.
Due to an in-depth understanding of the technologies involved, products and operational requirements, 3P TECH’s skilled team can deliver bespoke cleanroom solutions to meet the needs of clients across a wide range of industries and businesses.
What are cleanrooms?
Cleanrooms are controlled environments in which the levels of pollutants, such as dust, airborne particles, bacteria, harmful vapors, gases and more are dramatically reduced, creating an environment that adheres to international regulatory standards.
Cleanrooms are made up of integrated systems that are dependent on a variety of factors including the internal layout of the rooms, the construction materials used, air filtration methods, airchange rates, air pressure, airflow patterns, temperature, humidity levels and the vibrations experienced throughout the system.
3p Tech’s Complete Cleanroom Service
3p Tech has the ability to provide the entire range of services required for the complete installation of a cleanroom from simple open area cleanrooms, to complicated integrated systems and modifications of existing facilities and systems.
3P Tech’s total turnkey cleanroom designs and build services include:
Analyzing process requirements and variables
Determining the cleanroom classification level required
Deciding on the most efficient, energy saving and cost effective approach
Identifying the types of materials and systems to be integrated
Designing and establishing a schedule for the project
Handling project management services throughout the installation process
Providing the client with resources in the form of documentation
Cleanrooms are typically divided according to different types of design depending on the type of industry and foreseen classification needs.
The following industries require installation of cleanroom technologies:
Pharmaceutical and veterinary Biotechnology Healthcare Hospitals Medical device manufacturers Fine chemistry Cosmetics
Electronic and micromechanics Optical Food and beverage Automotive Engineering Offices and workplaces Research and design laboratories
1-Nosocomial Infection Control
Nosocomial infections, also called “hospital acquired infections” (HAI) can be defined as “an infection acquired in healthcare facilities by a patient who was admitted for a reason other than that infection, meaning this infection was not present or incubating at the time of admission”.
Despite progress in public health and hospital care, infections continue to develop in hospitalized patients and may also affect staff of the facility, many factors influence the development of infection among hospitalized patients with a certain susceptibility to infection (e.g. compromised immunity; the increasing variety of medical procedures and invasive techniques that can create potential routes of infection; in addition, poor infection control practices may facilitate transmission).
The patient is exposed to a variety of microorganisms (bacteria, viruses, fungi and parasites) in various healthcare settings (e.g. operating theaters, intensive care units). Infection rates partly depend on the characteristics of various microorganisms.
A route of transmission may be from another person in the facility (cross infection) or from waterborne or airborne agents, contaminated objects, devices and materials (environmental factors) which subsequently contact susceptible areas of the body of both patients and facility staff.
Frequency and Impact of Nosocomial Infections:
HAIs are the main cause of death and increased morbidity among patients. Their frequency is increasing and constitutes a significant burden to the public health sector, entailing considerable economic costs where the increased length of stay for infected patients is the greatest contributor. In addition the emergence of multidrug-resistant strains of bacteria poses a high risk to patients and leaves healthcare professionals and institutions facing difficult situations.
Nosocomial infection rates in patients within a facility is an indicator of quality and safety of care. To this end, the development of surveillance practices to monitor the infection rate is an essential first step to identify local problems and priorities, and evaluate the effectiveness of infection control activities. As a second step, installing controlled environments consolidates routine precautions programs (e.g. cleaning, sterilization and disinfection) and promotes an effective process to decrease the frequency of HAIs.
In case of an outbreak, 3P tech has the ability to:
Support the infection control committee to detect sources of threats.
Provide corrective measures.
Identify possible areas of improvement as preventive measures.
In response to the needs of healthcare institutions, 3P TECH provides the following services:
Site audits to evaluate critical areas
The development of customized solutions that aim to control environmental risks for infection; this step includes installing or remodeling controlled environments within short timeframes, in a manner that does not alter existing service workflows.
Senior managers are assisted in creating infection control committees and implementing their processes, alongside being given access to all relevant policies and manuals; 3P Tech willhighlight the need for multidisciplinary inputs and cooperation (e.g. maintenance, healthcare providers).
Providing sufficient resources and training to support surveillance programs.
Conducting monitoring activities according to a yearly program
Targeted surveillance is usually undertaken for selected high-risk units on an ongoing basis, or for a limited period, focusing on selected infections. 3P Tech’s specialty is to intervene in the following units and systems:
Compressed Air Systems
Isolation Rooms (Protective Environment (PE) and Airborne Infection Isolation (AII)
Central Sterile Services Department (CSSD)
Intensive Care Units
Critical Care Units
Hospital Pharmacies (Standard Product
Preparations and Cytotoxic Preparations)
Bone Marrow Transplants
Stem Cell Applications
2- Turnkey Projects
3P Tech can provide turnkey solutions for newly constructed facilities and can perform innovative and fast track renovations for existing areas which are classified according to the three degrees of risk outlined below:
Low risk areas (e.g. administrative sections)
Moderate risk areas (e.g. regular patient units)
High risk areas (e.g. ICU, Protective Environments, Airborne Infection Isolation, Operation Theaters)
3P Tech can provide services ranging from site audits to design review and can propose corrective actions and full validation testing for cleanrooms, sterilization cycles, thermal processes and cleaning methods.
Commissioning, Validation and Qualification
Validation is the establishment of documented evidence that the equipment, procedures and processes in place will perform in a consistent and repeatable manner. This leads to the assurance of the constant delivery of a product, which complies with a given Quality Standard.
3P Tech’s goal is to guide and support our clients in ensuring their facility, utilities and equipment perform as intended. 3P Tech’s experienced team has the technical skills to allow clients to reach their deliverables successfully. We do that using a risk-based approach to identify critical Direct Impact Systems, equipment and processes.
Direct Impact Systems are those that could likely impact product quality and the safety of patients in healthcare settings.
3P Tech provides the following services:
1- Commissioning Project Management
Ensures systems, utilities and equipment are designed along the principles of Good Manufacturing Practice and Good Engineering Practice.
Developing and executing commissioning plans that support the overall project schedule
Developing commissioning documents (e.g., User Requirement Specification, Factory Acceptance Tests and Site Acceptance Tests)
Managing the commissioning activities of vendors, construction contractors, owners, and contract resources
Ensuring smooth transitions throughout by careful planning of qualification and validation activities
2- Qualification and Validation Support
Planning and coordination of activities with clients and related vendors
Implementation of the required documentation to support implementation of systems, utilities, equipment, and processes
Performance and Process Qualification to verify user requirements and specifications are met
Creation and execution of Environmental Monitoring Plans, according to our client’s critical processes and needs
The following industries require validation and qualification processes according to best industry practices and regulatory requirements where applicable:
Pharmaceutical and veterinary
Medical device manufacturers
Electronic and micromechanics
Food and beverage
Offices and workplaces
Research and development laboratories
Quality control laboratories
Direct Impact Systems necessitating qualification and validation services:
Sterilization systems and cycles: Steam sterilization, Hydrogen Peroxide (H2O2) sterilization, Ethylene Oxide (ETO) sterilization and dry heat sterilization
Clean compressed gases
Refrigerators and cold storage areas
Cleaning and decontamination systems
Warehouse Temperature Mapping
Validation of room fumigation and fogging cycles used for operation theaters, isolation rooms and other critical areas
Biotechnology and Pharmaceutical Applications
From meeting national and international regulatory requirements, to customizing flexible and modern approaches to the design of turn-key projects, and streamlining manufacturing operations, 3P Tech’s diverse range of consulting services sharpens your business.
3P Tech provides Engineering Procurement and Project Management (EPCM) for biotech and pharmaceutical industries.
Industrial Development & Optimization
Our consultancy services are applicable to both new build facilities and to renovations of existing manufacturing sites. Our know-how in engineering, testing, regulatory compliance, process consultancy and procedures for optimized efficiency can bring improved performance, safety and quality recognition to both your company and product.
3P Tech’s comprehensively trained team of engineers, auditors, installers and quality assurance staff develop a full understanding of the scope and processes involved in each project.
Thanks to their knowledge of modern best industry practices to assist clients in planning their operations and understanding their requirements, 3P Tech’s team can:
Identify the client’s need in terms of technical, operational and regulatory requirements for new plants.
Study the client’s current operational environment and create workflows to optimize outcomes and to create design plans for existing plants.
During the development and construction phases, 3P Tech can assist clients with:
Conceptual design development
Ensuring implementation of cost-effective and energy saving processes
Procurement and construction management up to commissioning, qualification and validation up to the start-up and handover phase.
Good Manufacturing Practice and Quality Assurance
From initial creation to process optimization, 3P Tech consultancy services are proactive in helping to manage quality assurance while following a risk-based approach, this includes setting baselines for:
Quality Systems meeting requirements with Good Manufacturing Practices (GMP)
Qualification and Validation policies
Quality Risk Management
Managing planned and unplanned changes (Deviation Management and Change Management)
Supplier Qualification Process
Readiness for Inspection by Regulatory Authorities
Employee Qualification and Training
Promoting continuous improvement
Environmental and Waste Management Processes
Through extensive consultancy and engineering services 3P Tech ensures GMP compliance which will allow clients to operate according to industry-leading standards and also to acquire drug marketing authorization from the relevant regulatory authorities.
3P tech offers global sourcing and tools to allow clients to select the optimal supplier for their needs as the safety and quality of products relies not only on compliant in-house, cost effective processes, but also on supplier selection, evaluation and surveillance.
3P Tech is an entirely independent firm with worldwide connections to international suppliers, auditors and consultants.
With years of experience in providing innovative solutions to complex issues, team development and operations management within pharmaceutical facilities, 3P Tech’s staff are aware of the challenges faced by their clients and have developed and executed international and regional projects that adhere to guidelines and regulations as set forth by regulatory authorities such as the FDA, EMEA, JFDA, SFDA and the GCC.
Indoor Air Quality Assurance
Good indoor air quality is increasingly being seen as a key factor when it comes to the health, comfort and productivity of any building’s occupants, including hospital patients, school children, office workers and anyone who spends long periods of time within a single space.
Air quality is related to temperature, humidity and airflow as many complaints are related to issues which can in turn affect levels of hazardous contamination. In combination with other factors such as lighting, ergonomic complaints and general job-related stress, poor air quality can distress occupants and lead to decreased levels of performance.
Consequences of Bad Air Quality
The drawbacks of bad air quality are numerous and can affect occupant health and productivity in a wide range of ways such as:
Health problems, including -but not limited to- eye irritation, allergic reactions
Reduced productivity due to discomfort or increased absenteeism
Deterioration of furnishings or equipment
Negative publicity due to an uncomfortable atmosphere
Liability issues due to concerns over staff health
Air Quality Services
3P Tech offers the following air quality services:
A pre-audit of the client’s indoor air quality
A visual inspection of the air treatment systems
An acoustic and brightness assessment
Measurement of the fresh air supply
Assessment of the building’s air filtration efficiency
Microbial contamination measurements
Chemical pollutant measurements
Temperature, hygrometry, CO and CO2 measurements
Suggestion and implementation of corrective measures
3P Tech offers simple and effective solutions for fume control and extraction for the following applications: