Aseptic Processing - Powder filling and stoppering

Aseptic Powder Filling & Stoppering Machine - XTREMA PWD

Powder microdosing machines -

MD Series

Ampoule filling and sealing machines - STERIFILL Ampoules Series

STERIFILL Ampoules filling and sealing machine is a linear filler suitable to process 4, 6 or 8 ampoules
at each machine cycle, according to the output required.
The machine has been designed following the criteria typically needed in aseptic environments, such as,
reduced dimensions, the geometry facilitating the unidirectional airflow, high ergonomic level, slim design.

De-pyrogenating tunnels
BLUE GALAXY is a series of de-pyrogenating tunnels designed to be inserted in production lines that require
continuous de-pyrogenation by means of dry heat.
The wide range of manufactured tunnels gives the possibility of satisfying any production requirements; in the same
way the high technology allows the use of these tunnels for any kind of application and this is why they can be easily
integrated in lines designed to handle high toxic compounds and/or in lines with isolators.

BLUE GALAXY Series

Model
X (mm)
W (mm)
L (mm)
H ( mm)
Upon request reduced
height (mm)
Power (kW)

550
FL
550
1.705
2.980
2.980
2.700
39

870 FL 870 FLS 1.250 FL 1.250 FLS 1.250 2FLS 1.250 3FLS
870
2.025
2.980
2.980
2.700

870
2.025
3.810
3.075
2.760

1.250
24.10
4.410
3.175
2.760

1.250
2.410
7.025
3.175
2.760

1.250
2.410
8.245
3.175
2.760

1.250
2.410
9.940
3.175
2.760

50

60

70

145

149

214

Linear vial washers - HYDRA Series

HYDRA linear washers are specifically dedicated to the decontamination of injectable vials, resulting from specific
research into the decontamination of containers for injectable use.
The standard version is equipped with 8 washing stations entirely made of 304 or 316 st. st. and designed according
to cGMP standards.
This range of machines is suitable for different vial sizes and available at different output speeds:
HYDRA 1000: output speed up to 175 pcs/min
HYDRA 1300: output speed up to 300 pcs/min
HYDRA 1500: output speed up to 500 pcs/min
HYDRA 1800: output speed up to 600 pcs/min

Rotary vial washers - VEGA Series

Rotary washing machines of the VEGA Series are designed for washing vials, bottles, ampoules and unstable
cylinder-shaped containers.
Specifically built to allow strict decontamination methods, they are suitable for the removal of both dilutable and nondilutable particles.
VEGA 4: 100 - 200 pcs/min
VEGA 6: 150 - 300 pcs/min
VEGA 8: 200 - 400 pcs/min

Decontamination technology: external vial washers - HYDRA 100 and

HYDRA 300
Decontamination of vial external surfaces involves the destruction or removal of any possible product residual so as
to prevent them infecting the operators and cross contamination between containers and machine, as well.
The HYDRA 100 and 300 external washers are designed to achieve this aim, thanks to their washing cycle
features, which can comply with the actual requirements of the aseptic environments.
The HYDRA Series external washers are the ideal solution for any output range requirement:
From low to medium speed: HYDRA 100 linear washer the ideal completion for aseptic processing lines, up to
120vpm;
From medium to high speed: HYDRA 300 rotary washer for higher speed lines, up to 300vpm.

There must be a centralized area for reprocessing medical equipment/devices.

Reprocessing
performed outside the centralized area must be kept to a minimum and must be
approved by the
Infection Control Committee or those accountable for safe reprocessing practices
and must conform to
the requirements for reprocessing space. In smaller settings, such as clinics or
offices in the
community, this refers to any segregated area where reprocessing of
equipment/devices takes place,
away from clients/patients/residents and clean areas.
Recommendation 11
The policies of the healthcare setting shall specify the requirements for,
and frequency of, education
and training as well as competency assessment for all personnel involved
in the reprocessing of medical
equipment/devices.
Recommendation 12
All aspects of reprocessing shall be supervised and shall be performed by
knowledgeable, trained
personnel.
Recommendation 13
Managers, supervisors and staff involved in reprocessing have completed
a recognized
qualification/certification course in reprocessing practices.
Recommendation 14
A plan must be in place for each person involved in reprocessing to obtain
certification
qualification.
24
The central processing area(s) ideally should be divided into at least three areas:
decontamination,
packaging, and sterilization and storage. Physical barriers should separate the
decontamination area
from the other sections to contain contamination on used items.
In the decontamination area, reusable contaminated supplies (and possibly
disposable items that are
reused) are received, sorted, and decontaminated. The recommended airflow
pattern should contain
contaminates within the decontamination area and minimize the flow of
contaminates to the clean
areas.
The American Institute of Architects recommends negative pressure and no fewer
than six air
exchanges per hour in the decontamination area (AAMI recommends 10 air changes
per hour) and 10
air changes per hour with positive pressure in the sterilizer equipment room.

The environment where cleaning/decontamination is performed must:

a) have adequate space for the cleaning process and storage of necessary
equipment and supplies;
b) be distinctly separate from areas where clean/disinfected/sterile
equipment/devices are handled
or stored;
c) have easy access to hand hygiene facilities;
d) have surfaces that can be easily cleaned and disinfected;
e) have slip-proof flooring that can withstand wet mopping and hospital-grade
cleaning and
disinfecting products;
f) have restricted access from other areas in the setting and ensure one-way
movement by staff.
Decontamination work areas shall be physically separated from clean and other
work areas by walls
or partitions to control traffic flow and to contain contaminants generated during
the stages of
cleaning. Walls or partitions should be cleaned regularly and be constructed of
materials that can
withstand cleaning and disinfection.
Decontamination sinks:
a) shall be designed and arranged to facilitate soaking, washing and rinsing of
equipment/devices
with minimal movement or delay between steps;
b) should be adjacent to waterproof counter tops and a backsplash;
c) shall not have an overflow;
d) should be at a height that allows workers to use them without bending or
straining;
e) should be large enough to accommodate trays or baskets of instruments;
f) should be deep enough to allow complete immersion of larger devices and
instruments so that
aerosols are not generated during cleaning; and
25
g) should be equipped with water ports for the flushing of instruments with lumens,
if appropriate.
The packaging area is for inspecting, assembling, and packaging clean, but not
sterile, material.
The sterile storage area should be a limited access area with a controlled
temperature (may be as high
as 24oC) and relative humidity (30-60% in all works areas except sterile storage,
where the relative
humidity should not exceed 70%).
The floors and walls should be constructed of materials capable of withstanding
chemical agents used
for cleaning or disinfecting. Ceilings and wall surfaces should be constructed of nonshedding
materials.

Hand hygiene facilities should be located in all personnel support areas and at all
entrances to, and
exits from, the decontamination area. Hand hygiene facilities should include:
a) accessible hand washing sinks with hands-free controls, soap dispensers and
paper towels;
and/or
b) alcohol-based hand-rub (ABHR).

Solution Filtration Area

1.
2.
3.
4.

Decartoning Room (3x3)

Turn Table (1x1)
Washing Machine (3x3)
Sterilisation Tunnel (2x5)

AMPOULES WASHING, DRYING AND DEPYROGENATION ROOM

Ampoules filling and sealing room

Ampoules Inspection Room

Ampoules Labeling and packaging Room

Recovery Room

Dry Powder Vial Department Layout for Medium Scale