ROJECCT DE ESCR API HAL F
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PR
ROJEC
CT DE
ESCR
RIPTIION STAT
S EME
ENT
APII PLA
ANT
IN HAL
H F
FAR (MAL
( LTA)
1 INTRODUCTION ................................................................................................................................. 3
2 THE AREA AND THE STRUCTURAL PROJECT ........................................................................................ 3
3 STAGE DIVISION ................................................................................................................................ 7
3.1 Stage 1: R&D, Pilot Plant ................................................................................................................... 7
3.2 Stage 2: Expansion of the Stage I – manufacturing area for commercial use ................................... 9
3.3 Stage 3: New Manufacturing Plant for expanding production........................................................ 11
4 Activity of departments ................................................................................................................... 14
4.1 Management and administration.................................................................................................... 14
4.2 Quality Control ................................................................................................................................ 14
4.3 R&D, PILOT PLANT ........................................................................................................................... 15
4.4 MAINTENANCE ................................................................................................................................ 16
4.5 PRODUCTION ................................................................................................................................... 16
4.6 WAREHOUSE .................................................................................................................................... 16
4.6.1 INDOOR STORAGE AREA .......................................................................................................... 17
4.6.2 OUTDOOR STORAGE AREA ...................................................................................................... 17
4.6.3 LOADING/UNLOADING AREA .................................................................................................. 18
5 EQUIPMENT .................................................................................................................................... 18
5.1 LABS ................................................................................................................................................. 18
5.2 R&D, Pilot Plant – Validation Batches (Stage 1) .............................................................................. 19
5.3 Commercial Manufacturing (Stage 2).............................................................................................. 19
5.4 Building Expansion (Stage 3) ........................................................................................................... 20
6 ............................................................................................................................................................. 21
7 NUMBER OF EMPLOYEES ................................................................................................................. 21
7.1 Parking area ..................................................................................................................................... 21
8 SAFETY ............................................................................................................................................ 22
8.1 FIRE PROTECTION REQUIREMENTS ................................................................................................. 22
8.1.1 Technical report ....................................................................................................................... 22
8.1.2 Conditions of accessibility and viability ................................................................................... 22
8.1.3 Division into compartments .................................................................................................... 22
8.1.4 Ventilation ............................................................................................................................... 22
8.1.5 Overcrowding of environments ............................................................................................... 22
8.1.6 Source of fire ........................................................................................................................... 23
8.1.7 Workers and/or other people exposed to fire risk.................................................................. 23
1
8.1.8 Compensation of fire risk (anti‐fire strategy) .......................................................................... 23
8.1.9 Buildings Resistance to fire...................................................................................................... 23
8.1.10 Division into compartments .................................................................................................... 23
8.1.11 Emergency Exits ....................................................................................................................... 23
8.1.12 Emergency light ....................................................................................................................... 23
8.1.13 Fire Extinguishers..................................................................................................................... 24
8.1.14 Fire Hydrants ........................................................................................................................... 24
8.1.15 Smoke Detection ..................................................................................................................... 24
8.1.16 Emergency management ......................................................................................................... 24
8.1.17 Prevention measures ............................................................................................................... 24
9 PRODUCT HANDLING REQUIREMENTS ............................................................................................. 25
9.1 Risk Analysis ..................................................................................................................................... 25
9.2 Drying Phase .................................................................................................................................... 26
9.3 Pressure in the finishing room......................................................................................................... 26
10 HEALTH AND SAFETY.................................................................................................................... 27
11 ENVIRONMENTAL IMPACT ........................................................................................................... 28
21 INTRODUCTION
STERLING S.N.I.F.F. Italia S.p.a. was founded in 1976 by current share holders, as a chemical
company with limited liability (Ltd) for the production of flavors for the food and pharmaceutical
industry. The base is in Corciano, province of Perugia.
STERLING S.N.I.F.F. Italia S.p.a. focused exclusively on steroidal products, exports around 95%
of its turnover, mainly to the USA, India, EU, Canada and Japan.
Sterling S.N.I.F.F. Italia S.p.a. manufactures under Good Manufacturing Practices, and has been
regularly inspected by AIFA (Italian Minister of Health) and US Food & Drug Administrator
approved since 2002.
The purpose of this Project Description Statement is to enable MEPA to take a screening decision
and if required, to prepare the Terms of Reference for an Environmental Impact Assessment, in
consultation with the Government entities, Non-Governmental Organizations and the public.
2 THE AREA AND THE STRUCTURAL PROJECT
Sterling SNIFF Italia S.p.a. has formed a Maltese Company, designated Sterling Chemicals Malta
Ltd, with the role of establishing and running the factory in Hal Far industrial Estate, site
HHF051X, as approved by MIP as Sterling Chemicals Malta Ltd. The industrial area is already
developed, and a number of other companies manufacturing active pharmaceutical ingredients and
finished pharmaceuticals are already present in close proximity to the site. The figures below show
the exact location on the map. The total area is about 3295 sq. meters. The building will be a brand
new construction in order to satisfy all the regulatory and company requirements. This is already
covered by MEPA Permit PA 4236/08.
Figure 1 ‐ Aerial View
3Figure 2 – Exact area
The factory will be built in accordance with the KNPD 2006 guidelines with the accessibility for
disabled restricted to the offices building. Access to the building will be via a main entrance
doorway at road level or internally via the car park. The various levels are accessed by means of a
passenger lift satisfying the KNPD criteria.
The intention of the company is to phase the production of the facilities according to the factory
activating/building new departments following a plan of 3 stages. The three distinct phases are
described hereunder:
1. Stage 1: Research & Development (R&D). For this Stage STERLING CHEMICAL
MALTA Ltd has already obtained the approval from MEPA (PA4236/08).
2. Stage 2: API Manufacturing Plant for commercial use that Sterling Chemical Malta
seeks to get approval from MEPA.
3. Stage 3: New Manufacturing Plant for expanding production area that Sterling
Chemical Malta seeks to get approval from MEPA.
For ease of reference, we are including hereunder the architectural plans of the project highlighting
the different work areas departments.
4Figure 3 ‐ Basement
Figure 4 – Level 0
Figure 5 ‐ Level 1
5Figure 6 – Level 2
Figure 7 – Roof
63 STAGE DIVISION
The following explains in detail how the operational structure is used in 3 different stages. Each
Stage is also indicated through figures.
3.1 Stage 1: R&D, Pilot Plant
R&D and Pilot Plant have the function to study, develop and optimize (in lab quantities) new
processes. The development is defined by:
Development at the plant in Malta and the transfer process from the establishment in Malta
to the Italian plant;
Development for the customer: a minimum quantity for the customer for the formulation
trials, and dossier registration.
The following areas will be activated:
R&D, Pilot Plant
Departments Workable areas Communal ownership
Management Offices Indoor parking area
Quality Control Office, laboratory, Sampling room Canteen
Pilot area 1 Conference room
Finishing area 1 Toilets
Research and Development
Related activities coutyard
Utilities Loading/unloading area
Repair shop
LPG tank area
Maintenance
all areas in which you need a mechanical and
construction repair
Indoor raw material storage
Liquid Storage wastes (outdoor)
Warehouse
Outdoor storage infiammable raw materials
Solid storage wastes (outdoor)
The following figure illustrates the interior layout of the ground floor building and outdoor spaces.
7Figure 1 Lay out Level zero after stage 1
QC/R&D office
QC/R&D lab Finishing area Related activities Storage solid waste
storage infiammable
LPG Tank Area Pilot area 1 Indoor Warehouse Repair shop
Office management raw material and waste
(raw material)3.2 Stage 2: Expansion of the Stage I – manufacturing area for commercial use
The company intends, after the regulatory activity, testing and approval of the sample by the customer,
to begin the production for commercial use .
Commercial Manufacturing
Departments Workable areas Level
Extension Pilot area 1 Level zero
Pilot area 2 Level zero
Production
Extension finishing area Level zero
Utilities Level one
Administrative Offices Level one
Archive Level one
Management
Meeting room Level one
Training Centre Level one
According to the activities that will take place during the first stage, the offices and the archives of
the zero level can be immediately used.
Therefore it will use the same premises of the Stage 1 with the introduction of new reactors for API
production, shown in following figure.Figure 2 Level one after stage 2
Finishing area pilot 2
Pilot area 2 Pilot area 13.3 Stage 3: New Manufacturing Plant for expanding production
The company intends to upgrade the manufacturing capacity of the factory completing the building
with new dedicated production lines and enlarging the offices with a new office floor:
Departments Workable areas Level
Offices Level zero
New Production area Level zero
Production
New Finishing area Level zero
Utilities Level zero
New laboratory of Research and
Level two
Development
Research & Development
Pilot plant Level two
Utilities pilot plant Level two
Maintenance Maintenance office Level two
Therefore it will use the same premises of the Stage1 and Stage2 with the introduction of new
production area for API production, shown in following figure.Production plant Stage 3 Figure 3 Level zero after stage 3.
Figura 4 Lay out of level zero for highlighting outdoor workable areas.
Solid waste warehouse External flammables warehouse
LPG Loading/Unloading4 Activity of departments
4.1 Management and administration
The management role involves not only the coordination, the leader of a group of worker,
represented by the human resources available to the company or part of the company
(organizational unit) under its responsibility, but also the decision-making planning and
management to ensure the achievement of results in line with corporate goals and satisfy
stakeholders, ie the entities (individuals or organizations) stakeholders towards the company.
Belong to this department employees who work in a office administration, contact customers
and suppliers, etc..
4.2 Quality Control
Are prepared by the laboratory QC (and consequently of its analysts) sampling operations of
the raw materials, the production intermediates and finished products, In particular, the
sampling takes place inside the weighing chamber upon activation of the intake system . In
particular, the analyst must label the sample containers should check its appearance and
smell, fill in the product label.
QC task of recording of samples of the raw materials, the starting materials and packaging
materials. E 'task of QC prepare and store the samples against, in particular the amount must
be sufficient execution of at least two complete analyzes, against the samples are stored in a
special cabinet in which is present a Hygrothermograph for monitoring the temperature and
of the' relative humidity. The finished products must be stored for up to one year after the
closure of the stability program. And 'the task of the laboratory Prepare standard chemical-
physical internal selecting a batch having the highest possible quality characteristics,
characterizing by:
Identification: by spectroscopic analysis and HPLC;
Title using the formula 100 - (purity solvents, ash, Karl Fischer)
The analyzes’s results will be subjected to a critical review by the responsible QC. All tests
shall be recorded on the appropriate analysis notebooks. In general, the routine analysis
involves the following steps:
Issuance of the request for analysis;
Assigning the Required Number of Analysis;
Operations Analysis and preliminary checks (checking the quantity, availability and
conformity of reagents, workbenches and equipment to be used);
Operations and checks during the analysis:
Final operations (replace reagents, clean benches, hand analysis report to the Head
QC);
Issuance of the judgment of Conformity according to the results of the analysis;
Issuance of the certificate of analysis which is the official document accompanying
the goods which are outside the companyEach analysis must be carried out faithfully applying the method of analysis into force
4.3 R&D, PILOT PLANT
The objective is the development of processes which are going to be performed later in the
production plant and to prepare the small quantities that will be used both by our company
and by our customers in advanced formulation development trials, dossier preparations and
registration. The department of research and development is designed to meet the needs of its
customers through multi-step operations such as:
Optimization of synthesis processes already underway;
New synthesis and development of existing ones;
Isolation, characterization and synthesis of impurities;
Validation of processes for the synthesis
The department in stage 1 consists of a laboratory, pilot plant and a finished area. In stage 3
the entire department will be relocated to one level and the current pilot area 1 will be a
production line for commercial use
The quantities that will be manufacture are to be considered as “development quantities”.
Stage 1
Process areas
The process area function is to develop, optimize, synthesize and purify Active
Pharmaceutical Ingredients and intermediates with research operations. The following
operations will be performed:
Solid loading through vacuum or hatch
Loading from other reactors, hose connection
Addition/dosing of liquids
Distillation/reflux control and unloading
Atmospheres (nitrogen, vent, vacuum) operation
General inspection of the contents of reactors and some local indicators
Reactor unloading, to filters, centrifuges other reactors and drain, hose connection
Liquid-liquid separation
Pumping and filtration/purification operations, hose connection.
Finishing area
The Finishing area function is to isolate and dry Active Pharmaceutical Ingredients and
intermediates. The following operations will be performed:
Filter loading control, hose connection
Change of exhaustion sleeve filters in filters
Filtered cake washing
Filter discharge to drums
Loading from drums to driers
Discharge from driers to drums
Weighing and sampling of drums
Stage 2
No changes
15Stage 3
New R&D lab, pilot plant and finished area of pilot plant in livel 1
4.4 MAINTENANCE
The maintenance department, coordinated by the technical department of the company,
primarily by repair of mechanical, electrical and building. It is equipped with a repair shop. In
stage 3 the technical office will be located on the level 2.
Stage 1
Repair shop
Stage 2
No change
Stage 3
Technical office in the level two
4.5 PRODUCTION
Production plant for commercial use is divided in two areas:
Production lines
Finishing area
In stage one, the system consists of reactors, centrifuges, filters and dryers will be available to
the department of research and development while in stage 2 will be the first production line
and finishing for the generation of active ingredients for commercial use. In stage 3 will be an
extension of the production department with new reactors, centrifuges, filters, dryers, etc.
Stage 1
No yet built
Stage 2
Pilot area 1
Pilot area 2
Finishing area 1
Finishing area 2
Stage 3
New production area
New finishing area
The services associated with the production (utilities) such as nitrogen, steam, vacuum,
compressed air and related equipment are associated with production lines and increase with
them
4.6 WAREHOUSE
The magazine is structured in such a way as to have available a control office and where the
activity is carried administrative and bureaucratic and more premises in which the various
16operations described later take place. It has three workable areas, Indoor storage area,
Outdoor storage area, Unloading/Loading area.
4.6.1 INDOOR STORAGE AREA
Indoor storage area is divided in four subareas:
Raw materials warehouse;
Finished products warehouse;
Sampling/weighing room;
Packaging room;
Raw Material warehouse
The Raw materials warehouse function is to stock all the raw materials Prior to the placement
of goods in the intended position they must be placed on platforms to avoid any possible
confusion between different goods or different lots of the same item. Heavier goods will be
placed at the bottom while the goods are to be analyzed by the Quality Control laboratory
must be placed in "quarantine area" and then, once approved, transferred to the "approved
area". Le merci respinte sono invece trasferite nell’apposita area e identificate mediante
l’apposizione dell’etichetta rossa “Respinto”
The raw materials product storage holds drums/containers of solid product in pallets stored in
shelves at up to six levels.
Finished products warehouse
The Finished products warehouse function is to stock all the finished product and
intermediates.
The finished product storage holds drums/containers of finished solid product in pallets
stored in shelves at up to six levels.
Sampling/weighing room
Sampling/weighing operation is performed in this area. In the weighing room takes the
charge of raw materials useful for the production, quality control laboratory and to research
and development
The area must be well ventilated to avoid smells and concentrations of noxious vapours. The
area must be kept at room temperature, to avoid hot temperatures affecting product. The
sampling activity is to carry out the sampling of raw materials or finished products in order to
assess the quality
Packaging room
In this warehouse will be positioned secondary packaging for packaging and that is those not
in direct contact with the products (drums cardboard or aluminum, boxes of paper or
cardboard).
4.6.2 OUTDOOR STORAGE AREA
Outdoor storage area function is to stock flammable products. The area will be covered and
protected.
Storage infiammable wastes
17The storage of hazardous and flammable waste liquids in tank is deposited on containment
basins. The storage area is open-air but sheltered by a steel roof to protect waste from the
elements (rain, excessive heat, etc.).The inner surface of the catchment area will be coated
with a quartz layer that guarantees the impermeability; the same flooring will be sloping in
the direction of collection wells arranged at the ends of the basin itself. Within the basin there
will be curbs to support the pallets.
Storage solid wastes
This area will be dedicated for the storage of non-hazardous waste materials such as paper,
cardboard, plastic, glass, metal that will be closed in container In this area one will find the
dedicated container for hazardous solid waste such as activated carbon or contaminated tank.
Storage inflammable raw materials
The type of storage is equal to that of the liquid wastes.
4.6.3 LOADING/UNLOADING AREA
This activity involves operations monitoring compliance, quantity, integrity, cleanliness and
identity of the goods from external suppliers resulting in unloading by means of conveyor.
The activity will include the labeling of the different lots, the demands of analysis and
sampling, and finally the storage of the goods.
5 EQUIPMENT
The following chapter describes the general equipment that will be installed in the labs, scale
up plant, production plant and utilities area.
5.1 LABS
Counter
flow laminar hood
analytical HPLC
analytical GC
analytical KF
ultrasonic bath
Rotavapor
electrical vacuum drying oven
rotary vacuum pump
immersion refrigerator
Karl-Fischer
particle size analyser-Malvern
analytical IR
conductimeter
polarimeter
analytical UV
automatic titrate
muffle furnace
Accessories (flexible PTFE hoses, glassware, individual protective devices, precision
balances, heating plates, portable instruments to measure pH, temperature and clothing)
18HVAC system for laboratory
air treatment plant + filter group
5.2 R&D, Pilot Plant – Validation Batches (Stage 1)
Glassed steel pilot reactor
Teflon pilot reactor, nominal capacity 10 l
Accessories (flexible PTFE hoses, quick connections, individual protective devices, balances,
clothing, industrial furnishing, ecc.)
3 Reactors
Dryer 1
Buckner Filter
Vacuum pumps group
Stainless steel (AISI 304) blow-down tank
Polypropylene scrubber with filling media, liquid reservoir and circulating pump
Filter for compressed air
Air compressor, reservoir capacity 500 l, nominal displacement 40 m3/h
Package refrigerating chiller (+5°C)
Package refrigerating chiller (-25°C)
Active carbon filter
Air treatment plant + filter group – Pilot Plant
Air treatment plant + filter group – Finishing Area L1
Air treatment plant + filter group – SAS
Boiler 1
Nitrogen Tank
Cooling tower 1
Cooling tower 2
5.3 Commercial Manufacturing (Stage 2)
Glassed steel pilot reactor,
Teflon pilot reactor
Accessories (flexible PTFE hoses, quick connections, individual protective devices, balances,
clothing, industrial furnishing, ecc.)
3 Reactors
Dryer 1
Buckner Filter
Vacuum pumps group
Stainless steel (AISI 304) blow-down tank
Polypropylene scrubber with filling media, liquid reservoir and circulating pump
Filter for compressed air
Air compressor, reservoir capacity 500 l, nominal displacement 40 m3/h
Package refrigerating chiller (+5°C)
Package refrigerating chiller (-25°C)
19Active carbon filter
Air treatment plant + filter group –Pilot Plant
Air treatment plant + filter group – Finishing Area L1
Air treatment plant + filter group – SAS
Boiler 1
Nitrogen Tank
Cooling tower 1
Cooling tower 2
4 Reactors
Hastelloy manual discharge centrifuge, Ø 1250 mm + waste water discharge section 1
Hastelloy manual discharge centrifuge, Ø 1250 mm + waste water discharge section 2
Dryer 2
Boiler 2
Air treatment plant + filter group – L1
Air treatment plant + filter group – Finishing Area L2
5.4 Building Expansion (Stage 3)
Glassed steel pilot reactor
Teflon pilot reactor
Accessories (flexible PTFE hoses, quick connections, individual protective devices, balances,
clothing, industrial furnishing, ecc.)
3 Reactors
Dryer 1
Buckner Filter
Vacuum pumps group
Stainless steel (AISI 304) blow-down tank
Polypropylene scrubber with filling media, liquid reservoir and circulating pump
Filter for compressed air
Air compressor, reservoir capacity 500 l, nominal displacement 40 m3/h
Package refrigerating chiller (+5°C)
Package refrigerating chiller (-25°C)
Active carbon filter
Air treatment plant + filter group – Pilot Plant
Air treatment plant + filter group – Finishing Area L1
Air treatment plant + filter group – SAS
Boiler 1
Nitrogen Tank
Cooling tower 1
Cooling tower 2
4 Reactors
Hastelloy manual discharge centrifuge, Ø 1250 mm + waste water discharge section 1
Hastelloy manual discharge centrifuge, Ø 1250 mm + waste water discharge section 2
Dryer 2
Boiler 2
Air treatment plant + filter group – L1
Air treatment plant + filter group – Finishing Area L2
205 Reactors
Hastelloy manual discharge centrifuge, Ø 1250 mm + waste water discharge section 3
Dryer 3
6
This section has been omitted.
7 NUMBER OF EMPLOYEES
The project will implement new full-time employment on a shift basis as follows:
Stage 1 7 persons
Stage 2 6 persons
Stage 3 7 persons
Total 20 persons
The following skill levels are required:
Executive & administrative;
Managers;
Technicians;
Engineers;
Semi-skilled;
Unskilled;
7.1 Parking area
A car park at street level is being provided catering for 21 parking spaces including one for
exclusive use by persons with disability as per KNPD guidelines. Total number of employees
envisaged up to stage 3 is 20 persons, which will be spread out in two shifts such that at any
one time the maximum number of employees on the premises will be 15. Two spaces are
being reserved for visitors.
218 SAFETY
8.1 FIRE PROTECTION REQUIREMENTS
8.1.1 Technical report
Dangerous substances
Because of the nature of Sterling’s steroidal chemistry, in case of fire it is more appropriate to
use powder instead of water as a mean of fire extinguishing (some exothermic reactions could
be activated by the presence of water).
Stage 1
The quantities involved are very low because of the nature of the stage 1 (R&D and pilot
plant).
Stage 2 and Stage 3
The multipurpose manufacturing area, including the indoor and outdoor warehouse, is at this
stage active. In all manufacturing areas dangerous and inflammable substances are used,
however, the quantities involved are low because these are stored outside, in the open air
warehouse. In steroids production lines there are some dangerous substances, which are
inserted in some reactors. Dangerous substances and the others which are necessary to the
production, are stored in minimum quantities in the warehouses and sent to the appropriate
production line.
8.1.2 Conditions of accessibility and viability
The areas, where the discussed activities are performed are accessible by Fire Department
vehicle and have a minimum width greater than 4 m and have no headroom restrictions.
8.1.3 Division into compartments
The buildings is divided into compartments in order to minimize the fire risk and its eventual
propagation. The choice of compartments has been made focusing the attention to
environment safety compatibly with productive needs and local regulations.
8.1.4 Ventilation
Mechanical ventilation plant is used to avoid the dispersion of dangerous substances in the
production area during the charging and discharging of the reactors. For the finishing and
filtration room there is an appropriate UTA that, besides controlling the ventilation levels,
also controls the humidity and the temperature, and maintains the environment in a slight
overpressure to avoid outside contaminations.
8.1.5 Overcrowding of environments
Rooms in the production areas are only accessible to the workers. People who are external to
the company are only allowed to access the office areas.
228.1.6 Source of fire
Inside the building the following possible sources of fire are considered:
- Electric plant
- Charge and discharge operations
It must be said that this probability is remarkably low because the electric plant will meet
ATEX standards. Regarding charging operations, the quantities of dangerous goods are kept
to a minimum and everything happens under controlled conditions.
8.1.7 Workers and/or other people exposed to fire risk
During the working operations the principal risks are in the pouring of substances, an
operation that happens outside, in the weighing area of the inflammable storage. During
charging of the reactors, the risk decreases drastically because handled quantities are smaller
and use a vacuum loading system. In the management of the plant and in the exercise of
activities, in the interest of safety, the following standards will be observed:
Use, control, maintenance of temperatures according the instructions provided by the
suppliers;
Electric plant to conform to the current technical regulations;
Control and maintenance of electric and mechanical equipment;
Installation, control and maintenance of the necessary fire garrison;
Training of staff regarding the rules of safety behaviour, basic emergency procedures
and on the use patterns;
Maintenance of a high quality level of the work environment (cleaning, tidy up, etc.).
8.1.8 Compensation of fire risk (anti-fire strategy)
The fire-fighting strategy is based on the following points:
8.1.9 Buildings Resistance to fire
The warehouse areas will be built with a resistance to fire of at least REI120.
8.1.10 Division into compartments
The building is divided into compartments separated by fire rated walls and doors.
8.1.11 Emergency Exits
Different compartments have emergency exits as necessary to guarantee the evacuation to a
safe outdoor area. During the day to day running of the plant, the staff must make sure that
the Fire Exit routes are maintained clear at all times.
8.1.12 Emergency light
Inside the building and near the emergency exits there will be automatic emergency lights
which will be activated in the event of a fire or power failure, indicating the safe way out of
the building.
238.1.13 Fire Extinguishers
In every compartments there will be powder extinguisher, type 21A 144BC, one for about
every 100 sq.m., at least. Extinguishers, pointed out by appropriate notices, are located in
strategic points, such as near the fire exits, and areas that are considered as high risk zone.
Every fire-fighting garrison will be adequately indicated by appropriate notices.
8.1.14 Fire Hydrants
As previously explained, because of the nature of Sterling’s steroidal chemistry, in case of
fire it is more appropriate to use powder instead of water (some exothermic reactions could
be activated by the presence of water). In any case, outside of each building, near fire exits,
there is a network of ring fire hydrants. Furthermore, there is a hydrant installed in the offices
area. Position and number are such as to guarantee the covering of every area; the ring
network is fed by the main reservoir. The fire hydrant system is supplied by a motor pump
installed outside the building. All the fire fighting garrisons will be sign-posted adequately.
8.1.15 Smoke Detection
Furthermore, a smoke detection system will be put in place (to comply with UNI) which
covers both the production areas which house the reactors and the filtering areas, and the
utility zone at the first floor.
8.1.16 Emergency management
the following will take place:
- a worker will be appointed head of security
- a plan for the actualisation and the control of the safety measures is to be implemented, with
a particularly regard to:
measures to prevent the occurrence of fire and its propagation (prohibition, exercise
precaution, controls);
control and maintenance of fire fighting garrison (extinguishing equipment, exit paths,
etc.);
procedures to follow in case of fire, through the elaboration of a emergency and
evacuation plan;
information and education of the staff.
8.1.17 Prevention measures
The prevention plan will be brought to the attention of the staff, focusing on the most
common fire dangers, with particular reference to:
storage and manipulation of inflammable goods;
rubbish and combustible waste storage;
usage of free flames or heat generation equipment;
24 usage of electric plant and equipment;
specific risk areas;
Furthermore, regular control will be carried out to guarantee:
the keeping of a safe environment;
the availability of exit paths;
the visibility of safety notices;
the safety of electric plant.
9 PRODUCT HANDLING REQUIREMENTS
9.1 Risk Analysis
In the loading of starting materials, the workers put the reactor under vacuum by the opposite
circuit. Considerable quantities of liquid starting materials are aspirated from their container
assembled to a fixed line with a flexible pipe and loaded in the reactor placing the localized
suction exactly on the entrance of the container.
In case of use of little quantities of liquid starting materials, workers use a membrane pump.
The solid is loaded from the hatch, placing the localized suction on it. To avoid the spreading
of vapours and/or powders in the work environment, the localized suction must be used by
the proper placing of the aspirant arm in cases as follows:
On the opening of drums and/or cistern during the charging and/or discharging of solvents
and/or bitterns. On the opening of reactors (generally the hatch) during the charging of solids
and/or liquids. On the opening of reactors (generally the hatch) during the drawing of
samples of the reaction mass. On any other possible vapours and liquids source which could
spread in the work environment.
The use of the localized suction doesn’t exclude and doesn’t replace the use of P.P.D.
(Personal Protective Devices) by the single worker.
Vapours and possibly powders which could escape from drums and/or cistern during the
charging of solids are aspirated by the mobile appendix of capitation located in the various
point of the plant and sent to the scrubber. Emissions which originate from the two manifolds
of the vacuum and the normal emissions produced in the heating or reaction phase, are
conveyed in a third collector, and go to the abatement column too. The condensate is then
discharged by falling in drums or cistern using an aspiration mouth.
The aspiration system will always remain in function, even when there is no processing
ongoing, so possible residual vapours could be aspired without spreading in the environment,
avoiding the rise of diffused emissions and guaranteeing total care of workers’ health.
25To keep work environments as clean as possible, operators must clean the pipes, samplers,
utensils, and other equipment after their use, demonstrating the execution of these operations
by filling in the appropriate documentation. They also have to verify integrity and cleaning
of the materials to use, as well as the availability, integrity and cleaning of P.P.D. and the
functionality of machinery and equipment after every use.
9.2 Drying Phase
Drying of solid and damp product takes place in the finishing rooms. This operation takes
place in a room with a light overpressure where there is a dryer under vacuum fitted with a
water system circulation heating jacket. During the drying, the product is kept at a constant
temperature of 70°C and under vacuum by an opposite group for vacuum. Vacuum pumps
deliveries are conveyed in the abatement. On completion, the finished product is placed in
double polyethylene bags and aluminium drums.
The entire area is conditioned by an opposite treatment unit which consists of a section to
deal with emission, one to deal with distribution and another one for expulsion.
In fact, the external air which is introduced into the finishing room is adequately filtrated,
temperature regulated, and at constant humidity. The air is sent back outside after passing
through a series of absolute filters for the complete elimination of any dust.
In order to work in the finishing room in conditions of maximum security, operators will have
internal procedures which determine the moving of products and staff inside the room, the
maintenance of filters and the control of the pressures.
It is obligatory that inside the finishing room, the opening of each door will be preceded by
the closure of the previous door to minimise losses in pressure.
9.3 Pressure in the finishing room
In the carrying out of proper work, in full compliance with the standards of good
manufacturing, and to avoid any possibility of contamination, a system of differences in
pressure is created between the various rooms that constitute the finishing area.
To guarantee work conditions in the finishing room, and to enable full compliance with the
standards of good manufacturing, one of the key issues is to have a highly efficient
ventilation system. For this purpose is essential that the installed filters are efficient, and
therefore, do not present anomalies, breakings, saturations or other issues which wouldn’t
allow satisfactory work conditions.
For this reason, daily control and periodical change of filters is necessary.
2610 HEALTH AND SAFETY
During working time, workers have the duty to leave their own clothes in the lockers located
in the changing room and to wear suitable work clothes (overalls, shoes, semi face pack or
full face pack with universal filters for organic powders and vapours, and glasses for
protection from chemical agents).
In the production department workers wear disposable Personal Protective Devices (full
overalls, overboots, cap, muffs, gloves) from the moment are in contact with finished
products, intermediates and starting materials, both solid and liquid. Disposable-P.P.D. must
be changed when workers handle finished products or different intermediates and in the
loading of starting materials for different process, in order to maintain a high level of
cleanliness and personal care, reducing to a minimum any possibility of contact with
chemical substances.
All the employees are requested to undergo appropriate training before commencement of
works to ensure the correct use of P.P.D. and execution of working procedures in order to
reduce and possibly eliminate any possibility of accident.
27Acquatic
ASPECT
Atmosphere
environment
ENVIRONMENTAL
AREAS
DEPARTMENTS
gases
fine dust
pollutants
IMPACT
Emissions
layer and / or
hazardous air
Producing odors
Increase of gases
Water consumption
harmful to the ozone
Increased amounts of
Increase of greenhouse
11 ENVIRONMENTAL IMPACT
Using machinery and
x
x
x
construction equipment
x
x
Waste
x
Structure maintenance
x
MAINTEINANCE
Plant maintenance
Transport (Staker)
Storage of raw materials
Weighing
WAREHOUSE
x
x
x
Using transport
Management and
x
production of waste
Transforming raw
x
x
x
PRODUCTION
materials into product
ENVIRONMENTAL IMPACTS
x
Using paper
using toner
OFFICIES
Sampling of raw
materials and finished
products
x
x
Chemical analysis
QUALITY
CONTROL
Storage of raw materials
LABORATORY
x
Chemical analysis
Production of product
x
x
AND
samples
RESEARCH
Supply and storage of raw
LABORATORY
DEVELOPMENT
materialsSoil utilization x x x x x
Water discharged into
sensitive receptors
Alteration of surface
water budgets and / or
x
underground
Soil and subsoil Soil contamination to
relapse dust and other
x
contaminants
Use of soil
x x
Alteration of the
chemical / physical / x
biological soil
Soil contamination to
relapse dust and other
Flora and fauna contaminants
Use of soil
Disruption of
ecosystems and
ecological networks
Ecosystems
Reduction of surface
quality and biological
ecosystems
29Impact on the
x
landscape
Alteration of the
Landscape
historical / social / x
economic
Changing the noise
x x x x x x x x x x
climate around the site
Alteration of the level
of vibrations in the
Climate noise and surrounding site
vibration Changing the noise
climate in the x x x x x x x
workplace
Alteration of the level
of vibration in the
working environment
Consumption of
x x x x x x x x x x x x x x x
electricity
Energy resources Consumption of fuels x x x
Consumption of water
Impact of light sources
Electromagnetism x
in the site
Production of non-
x x x x x x x x x x
hazardous waste
Waste
Production of
x x x x x x x x x
hazardous waste
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