Pharmaceuticals - Applications

PHARMACEUTICALS PROCESSES

Creating a contamination-controlled environment, for manufacturing sterile drug products, is a significant investment into protecting the production process, the product, but also the health of the people working there and the environment from the various risks of airborne contamination.

Creating a contamination-controlled environment, for manufacturing sterile drug products, is a significant investment into protecting the production process, the product, but also the health of the people working there and the environment from the various risks of airborne contamination.

The components of the ventilation systems used for this type of application must be carefully selected to guarantee the levels of environmental protection required.

With over fifty years’ experience in the sector of contamination-controlled environments and in producing HEPA and ULPA filters, SagiCofim has developed a range of solutions that meet the requirements of all the figures that design, make, certify and use contamination-control HVAC systems and production lines used for critical products.

In this specific market where Italian companies are often cited for their excellent quality standards, SagiCofim stands out for the completeness of its skills in both filter construction and in air diffusion and distribution solutions. Our solutions draw on our full range of air-treatment products for sterile environments, designed to work together in the best possible way across all phases (airflow regulators, silencers, filters and terminals, humidifiers).

GRADE A (ISO 4.8)

These include drug production facilities with a high risk of contamination, such as, for example:

  • Bottling, capping and ring-sealing areas
  • Production line feed areas (e.g. bowl feeders
  • Aseptic transit zones
  • Isolators

Grade B (ISO 5) areas are adjacent to Grade A zones and are in negative pressure.

Recommended

GRADE C – D (ISO 7 – 8)

These include areas used to produce less critical sterile drug products, such as, for example:

  • Preparation of products that will need subsequent sterilisation

Recommended

DEDUSTING

These are processing areas that contain pharmaceutical dust; the air extraction must, therefore, be controlled. A few examples include:

  • Drum mixers;
  • Blister packaging machines;
  • Tablet presses.

Recommended

BIO-SCIENCE

Creating a contamination-controlled environment, for manufacturing sterile drug products and biologically active substances (e.g. Vaccines, allergens, GM, cellular therapy products), is a significant investment into protecting the production process, the product, but also the health of the people working there and the environment from the risk of airborne contamination.

Creating a contamination-controlled environment, for manufacturing sterile drug products and biologically active substances (e.g. Vaccines, allergens, GM, cellular therapy products), is a significant investment into protecting the production process, the product, but also the health of the people working there and the environment from the risk of airborne contamination.

The components of the ventilation systems used for this type of application must be carefully selected to guarantee the levels of environmental protection required.

With over fifty years’ experience in the sector of contamination-controlled environments and in producing HEPA and ULPA filters, SagiCofim has developed a range of solutions that meet the requirements of all the figures that design, make, certify and use contamination-control HVAC systems and production lines used for critical products.

In this specific market where Italian companies are often cited for their excellent quality standards, SagiCofim stands out for the breadth of its skills in both filter construction and in air diffusion and distribution solutions. Our solutions draw on our full range of air-treatment products for sterile environments, designed to work together in the best possible way across all phases (airflow regulators, silencers, filters and terminals, humidifiers).

BIOSAFETY LABORATORIES

These environments contain potentially infectious micro-organisms, pathogens or animals, and include, for example,

  • Research laboratories
  • Processing zones
  • Diagnostic facilities
  • Biosafety cabinets
  • Fume hoods
  • Isolators

The laboratory’s classification level identifies, in descending order, the protection level necessary for staff, the environment and the community.

Recommended

GRADE A (ISO 4.8)

These include drug production facilities with a high risk of contamination, such as, for example:

  • Bottling, capping and ring-sealing areas e.g. For vaccines
  • Production line feed areas (e.g. bowl feeders)
  • Aseptic transit zones

Grade B (ISO 5) zones are adjacent to Grade A zones.

Recommended

CLASSE C – D (ISO 7 – 8)

These include areas used to produce less critical sterile drug products, such as, for example:

  • Preparation of products that will need subsequent sterilisation;

Recommended

Biosafety laboratories

These are environments designed to allow the safe handling of infectious materials in the laboratory environment.

They are classified into containment levels, from BSL1 (the lowest) to BSL4 (the highest), depending on the hazardousness of the microorganisms handled within them.

Grade A processing zone

The critical zone for high risk operations or for making aseptic connections by ensuring protection by first air (e.g. aseptic processing line, filling zone, stopper bowl, open ampoules and vials).

Normally, such conditions are provided by a localised airflow protection, such as unidirectional airflow work stations, RABS or isolators.

The maintenance of unidirectional airflow should be demonstrated and qualified across the whole of the Grade A zone.

HIGH CONTAINMENT ROOM

Rooms for the production of High Potency Active Ingredients (API and HP-API) that require high levels of containment for the protection of personnel employed, for the protection of the product and the external environment.

ATEX process rooms

SOLUTIONS FOR POTENTIALLY EXPLOSIVE ATMOSPHERES  ATEX_col

Our solutions for potentially explosive atmospheres refer to European ATEX Directive (Explosive Atmospheres) of 26 February 2014 n° 2014/34/UE , which was implemented in Italy by memorandum n°79499 of the Ministry for Economic Development of 21 March 2016 and came into force on 20 April 2016…

Our solutions for potentially explosive atmospheres refer to European ATEX Directive (Explosive Atmospheres) of 26 February 2014 n° 2014/34/UE , which was implemented in Italy by memorandum n°79499 of the Ministry for Economic Development of 21 March 2016 and came into force on 20 April 2016, on the harmonisation of the laws of the Member States relating to protection systems and devices intended for use in potentially explosive atmospheres. The directive requires all products sold within the European Union to be ATEX certified, regardless of their place of manufacture and the legislation in force there, if they are installed in locations deemed to be at risk of explosion.

LINKS TO THE ATEX DIRECTIVE

Areas are deemed as dangerous when, under certain conditions, explosive atmospheres may develop.

Explosive atmospheres are caused by a mix of air and gas, vapour, fumes or combustible dust that rapidly combust (explode) when lit.

According to the directives, potentially explosive atmospheres can be divided based on the chemical nature of the explosive substance into:

Directive 99/92/CE is linked to the ATEX directive and stipulates the classification of zones at risk of explosion as described below.

Directive 99/92/CE requires all areas in the workplace to be classified by way of a risk analysis which identifies the critical areas and indicates the safety measures to be adopted for the activities to be carried out in said areas.

It is the operator’s responsibility to classify the zone in accordance with the type of atmosphere present.

Gaseous atmospheres are further subdivided into groups of gas and on the basis of the maximum surface temperatures of engines.

THE ATEX DIRECTIVE SUBDIVIDES EQUIPMENT INTO TWO GROUPS

group I

Mining equipment (danger of firedamp or combustible dust).

group II

Equipment intended for use in areas in which explosive atmospheres may develop.

This group is subdivided into three categories:

Category 1

Category 2

Category 3

Condizioni generali di vendita

Condizioni generali di acquisto

General Conditions of Purchase