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.
STATE-OF-THE-ART CLEANROOMS
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.
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 total turnkey cleanroom designs and build services include:
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
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:
In response to the needs of healthcare institutions, 3P TECH provides the following services:
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:
Target Systems
Target Units
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:
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.
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
2- Qualification and Validation Support
The following industries require validation and qualification processes according to best industry practices and regulatory requirements where applicable:
Direct Impact Systems necessitating qualification and validation services:
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:
During the development and construction phases, 3P Tech can assist clients with:
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:
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:
Air Quality Services
3P Tech offers the following air quality services:
3P Tech offers simple and effective solutions for fume control and extraction for the following applications: