Pharmaceuticals

Pharmaceuticals

From design to installation and maintenance, SagiCofim applies its many years of experience to facilities in the pharmaceutical industry, installing innovative solutions into high-technology environments, where the risk of contamination must be zero, optimising the cost of investment and simultaneously reducing energy consumption.

Mission

SagiCofim, a specialist in air diffusion and distribution, proposes innovative solutions for high-technology environments, where the risk of contamination must be zero, both in standard situations and under extreme operating conditions.

This means guaranteeing the best production processes (that keep waste to a minimum) and the health and well-being of workers, as well as protecting the surrounding environment, all against the dual backdrop of reducing emissions and saving energy.

From design, to installation and maintenance, we provide a wide range of products and tailor-made solutions, all fully tested and certified, which will optimise the cost of investment without compromising on quality or service life.

Laboratories, complete production chains, individual areas and devices are all fields in which our products and solutions get down to work, to deliver constantly sterile air that is free from the risk of contamination.

We are the best choice of partner for designers and installers in the pharmaceuticals industry (and also electronics, food sectors, etc.) who are looking for a single, well-rounded contact; we are also the right choice for anyone looking simply for high quality individual components.

Our extensive experience in the pharmaceuticals sector – proven by our collaborations with the industry’s largest companies – has shown us that right from the very beginning of the design process, the client and the designer must work together to define the project objectives and to make the right technical choices to meet them, to guarantee:

  • the quality of indoor air to control environmental contamination, the production processes and to protect workers, by maintaining optimum quality requirements;
  • the physical and dynamic isolation of individual environments;
  • the optimum life cycle of the installation. Nowadays, Life Cycle Cost – which concerns both the economic and energy aspects of a project, but also the guaranteed performance of the systems – is a determining factor, both on a design and management level, when assessing the quality and suitability of a system or installation.

Our convictions, reflected in our professional practices, have allowed us to collaborate on important design studies and with service providers.

We have designed and implemented many high-level integrated solutions for various leading pharmaceutical companies operating in Italy and Europe.

SagiCofim is capable of ensuring this level of performance because it develops, designs and manufactures at the highest level: it owns its own factories with advanced production processes, equipped with highly automated production lines for building aeraulic components and the whole range of filters and filtering systems. It feeds and updates the production processes through its specialist Research, Development and Testing Centre, that operates in close collaboration with the Polytechnic University of Milan on both the theoretical research phases and on carrying out and validating tests carried out in the field.

At its headquarters in Cernusco sul Naviglio (Milan), it also has its filter and filtration system manufacturing unit; here there is a technologically advanced testing circuit, annexed to the production line, for testing every high and very high efficiency HEPA and ULPA filter in accordance with EN 1822 standards, to further guarantee the quality of every product that leaves the factory.

The aeraulic components are produced at its Bareggio facilities, outside Milan, and in Teglio in Valtellina (Sondrio).

SagiCofim’s international vocation is demonstrated through projects carried out and underway in several European and international locations. Its French branch in Lyon, concerned primarily with the commercial side of the business, is one such example. It also has a presence in other European countries through operative agents with proven technical skills, who are able to evaluate and advise on the situation in hand.

Beyond Europe’s borders, Sagicofim has a particularly well-established, recognised presence in certain areas undergoing rapid industrial development, such as Korea, India and the United Arab Emirates.

Critical issues and benefits

Factors to consider during the design and initial installation

The first factor to consider is the overall vision: the central objective is air quality, not the individual machine or device to be installed. It is not, therefore, just the installation of the individual parts that needs consideration, but the synergy between them and the overall long-term effect on various aspects: human, production, environmental and ecological..

What are the factors to consider in the design and initial installation of a system which ensures the quality and protection of the product, the process, operators and the environment?

The first factor to consider is the overall vision: the central objective is air quality, not the individual machine or device to be installed. 

It is not, therefore, just the installation of the individual parts that needs consideration, but the synergy between them and the overall long-term effect on various aspects: human, production, environmental and ecological.

It is from this perspective that Sagicofim, as a leading partner in the field, provides its well-rounded experience and knowledge to achieve the best results for the context at-hand. 

We can supply the various components and elements of a HVAC system as well as specific custom solutions.

The finer details:

  1. An essential factor in any project is a proper risk assessment, and calculation of the residual risk.
  2. Once the minimum air contamination level that must be maintained is known as well as the physical and climatic features of the environment in which the process will be carried out (laboratory, production line, etc.), in accordance with the regulations in force, the designer will choose the appropriate components to guarantee the project parameters.
  3. Filtration systems should be chosen and dimensioned in such a way that the overall cost of their entire lifespan is taken into account by way of a proper LCC (Life Cycle Cost) analysis, which also takes the maintenance aspects into consideration.
 

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MAINTENANCE FACTORS TO CONSIDER

Replacing used filters and filtration parts requires attention, skill and the use of appropriate PPE. Disposal of these elements must also comply with strict regulations, depending on the pollutants involved and how dangerous they are. Protection of people and the environment must be at the top of the list of priorities..

What factors must be considered to ensure that air-filtration and diffusion systems are kept in the best safety conditions?

Firstly, it is essential to know and follow the procedures stipulated by the manufacturer of the system and the filters that need replacing. It all comes down to safety, and that is why the quality of such procedures must be assessed even from the design phase, as an integral part of the requirements.

Replacing used filters and filtration parts requires attention, skill and the use of appropriate PPE. Disposal of these elements must also comply with strict regulations, depending on the pollutants involved and how dangerous they are. Protection of people and the environment must be at the top of the list of priorities.

In addition to the operating procedures stipulated by the system and filter manufacturers, companies should also apply their own codes of conduct and regulations which must be rigorously obeyed, to ensure that operational efficiency is never compromised. 

As well as the safety implications, remember that an inefficient filtration chain (for its own inefficiencies or through incorrect or insufficient maintenance) has a significant effect on a facility’s performance as well as on a company’s energy consumption.

 It can actually defeat the object of costly investments and put production quality at risk, by increasing waste and compromising the processes.

The most effective and recommended answer to these types of problem is Life Cycle Cost (LCC), which analyses and calculates all the problems and provides a properly efficient solution. 

This way the energy saving dimension goes hand in hand with performance and environmental considerations, helping to properly ascertain the actual costs of a project over the short, mid and long-term of its service life.

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WHAT FACTORS NEED TO BE CONSIDERED WHEN CONSTRUCTING EQUIPMENT AND PROCESS LINES?

The critical nature of the environments they are intended for means that safety and reliability must be guaranteed. An essential part of skilful and careful planning, whether for process lines or equipment, is the astute choice of the appropriate filtration system.  It is this aspect, essential for guaranteeing the required performance, that must be selected for its uncompromising quality..

The critical nature of the environments they are intended for means that safety and reliability must be guaranteed. An essential part of skilful and careful planning, whether for process lines or equipment, is the astute choice of the appropriate filtration system. It is this aspect, essential for guaranteeing the required performance, that must be selected for its uncompromising quality.

Sagicofim is confident in its ability as a partner in this sector, with a service that goes above and beyond that of an ordinary supplier. Here’s why:

  1. Our profound knowledge of air filtration and distribution systems: this allows us to design and experiment in our own laboratories, and to validate and certify in accordance with regulations in force.
  2. Several decades’ experience in developing custom solutions for our customers, making us a leader in the industry.
 

REFERENCE STANDARDS FOR CONTAMINATION-CONTROL HVAC SYSTEMS

The European legislative framework is based on GMP (Good Manufacturing Practice) standards and on UNI EN ISO 14644-1..

European legislation and standards are based on the following references:
  • GMP Good Manufacturing Practice
There are two fundamental ways of constructing contamination-controlled environments with respect to where the air filters are positioned: horizontally on the ceiling, or vertically on the walls. In the first case, the filters may cover the entire ceiling or just part of it, depending on requirements. In terms of functionality, the air can be diffused in two ways: by unidirectional flow or by non-unidirectional flow. Air diffusion by unidirectional flow (laminar) is capable of achieving class 1 (M1.5) cleanliness levels, the maximum possible today. The HEPA or ULPA filters used are panel versions, assembled together on special frames that ensure airtightness and prevent any air bypasses. Air diffusion by non-unidirectional flow (turbulent) is capable of achieving cleanliness classes up to 1000 (=M4.5). Classificazione ISO 14644.1 EN
  • UNI EN ISO 14644-1
In 1996, ISO issued a standard that provided the acceptable limits of airborne particles in cleanrooms and cleanzones (ISO 14644-1). The reference particle limits provided in ISO 14644-1 are similar to the table contained in previous standard Fed. Std. FS 209 E (of 1992). The only noteworthy difference was the introduction of a new field or reference for particles of 1µm, which makes the classification of clean-environments more complete. There are also significant differences between the two standards in terms of verification and monitoring levels: indeed, in relation to the size of the contamination-controlled room or zone there may be either more or fewer verification points depending on the standard followed. There are also several conceptual differences between the two standards. It is therefore essential, right from the start of the design phase, to identify the reference parameters and standards to ensure proper control of the results. Classificazione ISO 14644.1 EN
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