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
- A laminar flow system (LAF) will guarantee
- a uniform airflow speed (0.36-0.54m/s) onto the work bench in open cleanrooms
- slower velocities if working in isolators or glove boxes.
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
- Terminal filters, DIF P, to guarantee worker well-being conditions are being maintained by absolute filtration to ensure the required level of cleanliness.
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
- Depending on the toxicity level, different filter grades may be required in order to achieve absolute filtration (e.g. HEPA filters) and a BIBO safe filter change system
- Depending on the explosion class of the dust present, it may also be necessary to use ATEX components.
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
- Because of their characteristics, the above-mentioned environments must always be kept at negative pressure.
- Due to the critical nature of these environments, all the components installed are made from stainless steel AISI 304 or 316L to guarantee complete sanitisation.
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
- A laminar flow system (LAF) will guarantee:
- a uniform airflow speed (0.36-0.54 m/s) onto the work bench in open cleanrooms
- slower velocities if working in isolators or glove boxes.
- When high risk materials are present (e.g. pathogens), these are at a higher pressure with respect to the process, which is therefore in negative pressure.
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
- Terminal filters, DIF P, to guarantee worker well-being conditions are being maintained by absolute filtration to ensure the required level of cleanliness.
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.
The best solution
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.
The best solution
-
Integrated HEPA and ULPA terminal filters
DUG-B, DUG-A -
Automated VAV rectangular regulator
RSVQ, RSVQS, RSVQH -
AIR EXHAUST GRILLES FOR CONTAMINATION-CONTROLLED ENVIRONMENTS
DEC A, DEC S -
DELTA SERIES ABSOLUTE FILTERS FOR UNIDIRECTIONAL FLOWS
AB, MAB, DAB, LPD -
Soffitti filtranti per ambienti a contaminazione controllata
LAF
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 
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:
- Areas where GAS is present, indicated with the letter G
- Areas where DUST is present, indicated with the letter D
- Areas where both DUST and GAS is present, indicated with the letters GD
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
- Very high level protection equipment
- Used in areas where it is highly likely that an explosive atmosphere will be continuously developed.
Category 2
- High level protection equipment
- Used in areas where an explosive atmosphere is likely to develop.
Category 3
- Normal level protection equipment
- Used in areas where an explosive atmosphere is unlikely to develop.
