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Beyond Technology
The new business model from Romaco sets valuable incentives prerequisite for the development of comprehensive solutions.
for meeting customer requirements. For the design of innovative Romaco promises its customers professional project handling,
solutions, Romaco relies on its unique knowledge portfolio. With fast delivery times and a reliable service. Through this, Romaco
its diverse brands, Romaco focuses on important technological provides its customers with a considerable boost to their earning
fields of competence. The single product lines offer the optimum and financial power.
Romaco wins over its customers by offering Romaco offers integrated solutions for Romaco is synonymous with European
an outstanding price/performance ratio over the growing markets of pharmaceuticals, engineering on the highest level. With
the entire life cycle of its products. In this cosmetics, food and industrial applications. its seven brands, the company is widely
way, customers can systematically optimise Here, the customer benefits from the recognised around the world. Continuity
their cash flow. With efficient production synergetic effects that result from the close and progress are the keys to a strong posi-
and service management, Romaco prepares collaboration of all the Romaco brands. This tioning on the market. Romaco relies on
its customers for future long-term commer- internal technology transfer imparts a con- the profound knowledge and the long-time
cial success. siderable development potential and is the experience of its employees.
basis for comprehensive solutions.
» Romaco provides you with the highest
possible flexibility when it comes to configuring
aseptic liquid filling solutions. «
Nicola Magriotis, Sales Director, Romaco S.r.l.
• Depyrogenation of glass vials and • Optimised for filling sterile pharmaceutical • Closing station either integrated in the • Closing station either integrated in
ampoules liquids liquid filler or available as a line the liquid filler or available as a line
• All vials pass through heating and • Suitable for filling glass vials component component
cooling chambers • Designed to handle containers 14 to • Standard closure with press-on rubber
• Containers heated to a maximum 68 mm in diameter and 35 to 200 mm stopper
of 340 °C in height • Special closure types for subsequent
• Temperature and compressed air • Variable filling volumes from 0,5 to 250 ml freeze drying
monitored continuously
Delivering Solutions Sterile Processes are a Must The concentration of particles and micro-
organisms has to be kept to a minimum
All Romaco solutions for filling sterile throughout the entire process. At the same
pharmaceutical liquids guarantee excellent time, the operator must be protected
sterility assurance levels (SAL). Conformity against direct contact with toxic medica-
with rigorous hygienic requirements is a tions. First-class containment solutions are
must, particularly in connection with liquid the answer.
pharmaceutical products for parenteral
administration.
High Barrier Protection Efficient and Reliable Simple to Operate Secondary Packaging Solutions
• RABS (Restricted Access Barrier System) • Advanced level of automation provides • Ergonomic design for optimal access and • Romaco Promatic PC 4000 continuous
• Vertical laminar flow systems absolute reproducibility ease of use motion cartoner
• Glove boxes for controlled access • Maximum flexibility through the use of • Product and format changes completed in • Romaco Promatic P 91 intermittent
• Integrated CIP (Cleaning in Place) and SIP servo technology quickly and efficiently motion cartoner
(Sterilisation in Place) systems • Selected process analytical technologies • Simple control and monitoring of all • Romaco Promatic SM 2000 stretch
(PAT) incorporated processes on the HMI panel with intuitive bander
• In-line check weighing system navigation • Romaco Promatic PAK case packer
High Performance Ensures Precise and Universal Transport Gripper Technical Highlights Exploiting Technologies
Smooth Handling • Containers with different diameters are • Maximum output: 24,000 containers Romaco Macofar WM 8000 Series
transported without having to change the an hour
The automatic, intermittent motion washing format • Separate “white” and “grey” areas
machines in the Romaco Macofar WM 8000 • Even the most difficult containers are • Washing principle allows combination
series are known for their exceptionally high gripped gently and efficiently of air and water
performance and flexibility. These machines • Containers optionally pre-cleaned in an
are renowned for their ergonomic design Variable Washing Cycles ultrasonic bath
and strict balcony architecture. The ultra- • Standard cleaning process with set of • Cleaned vials are automatically discharged
reliable transport system ensures precise special nozzles • Washing circuit sterilised with free-flow-
and smooth handling of cylindrical contain- • Washing cycle can be customised ing steam
ers, including those that are geometrically • Eight or nine stations possible per
unstable. Flexible, programmable washing washing cycle
cycles contribute to a thorough cleaning • Self-draining washing circuits
process that is easy to validate. • Additional wash, drying cycle or silicon-
ising can be integrated on request
Very compact washing station Internal and external cleaning station Precise needle centering into vials
Compliance with Strict Regulations Romaco Macofar Depyrogenation tunnels Technical Highlights Exploiting Technologies
• Containers heated to a maximum of • Transport on a conveyor belt made of Romaco Macofar T Series
A pyrogen is a substance that induces 340°C using sterile air stainless steel wire mesh; no abrasion
fever. During the manufacture of parenteral • Sterilisation and depyrogenation with due to two anti-jam belts that advance
pharmaceuticals these substances must be a unidirectional laminar flow with the containers
removed from the product and from all con- • Vials cooled to ambient temperature in • Mesh belt sterilised by unidirectional,
tainers and stoppers. This process is known the downstream cooling area vertical laminar flows
as depyrogenation. The Romaco Macofar • Controlled environment conforms to • Integrity of the seal on the absolute filters
depyrogenation tunnels comply with even ISO 14644-1 and ISO 5 over the entire assured by ceramic fibre gaskets
the strictest regulations. tunnel length • Vacuum eliminates infiltration of non-ster-
• Validation with LAL test ile air through the gaskets
• Adjustable gates between
chambers ensure a constant laminar air
flow velocity
• Cooling chambers sterilised with dry air
High Speed Aseptic Filling Slim Design Integral Precision Exploiting Technologies
• Combination of balcony structure and • Available with various dosing systems: Romaco Macofar VF Series
The aseptic liquid fillers in the Romaco table-top design peristaltic or rotary piston pump
Macofar VF series combine top perfor- • Less than 600 mm between the front of • Very precise dosage of filling volumes
mance with completely reliable processes. the machine and the dosing station with a tolerance as fine as 0,5 %
These machines achieve a maximum output • Large gap between the filling area and • Vials transported, weighed, filled and
of 24,000 vials an hour with a filling volume the machine’s base plate stoppered with the help of servo motors
of up to two millilitres. Users can choose • Exceptionally compact machine • Linear configuration with positive trans-
from three different models with up to ten • Strict separation between the “white” port system
servo-controlled dosing syringes for con- and “grey” areas
tinuously filling the vials with pharmaceutical • Through-wall installation available as
liquids. Due to the linear positive transport an option
principle, the vials are always guided safely.
This is a great advantage, especially when Sterile Cleanroom Environment
unstable containers, such as those typically • No turbulent air movements in the vicinity
employed for freeze drying, are required. of the open vials
The VF series is the ideal solution for filling • Can be equipped with RABS or isolator
Small Parenteral Vials. technology
• Designed with laminar flow systems
• Vials can be blown prior to flushing with
nitrogen
Aseptic filling and closing Double indexing machine Dropper and screw cap application
The new generation of automatic Main Machine Features Technical Highlights Exploiting Technologies
capping machines • Outstanding capping quality is provided • Automatic adjustment of capping Romaco Macofar MAC Series
by individual capping stations handling pressure on each vial
The capping machines in the Romaco one vial at a time • Speed up to 24.000 vph
Macofar MAC series integrate the most • Sealing by means of individual idle blades • Setting of capping pressure from HMI
advanced technology for sealing cylindrical • Intermittent and continuous versions are • 100% actual capping pressure verification
glass vials with aluminum flip-off, alu-caps. both available and recording of data in batch report
The machines comply with all established • Automation and simple operation via • Configured for installation of a cRABS
guidelines and regulations for aseptic pro- intuitive touch panel (HMI) (Restricted Access Barrier System)
cesses. • Recipe management function • Minimum particles generation
• Recording and management of production • In line capping quality verification available
data as an option
• Ergonomic design, compact machine, • Rubber stopper presence and position
minimal footprint particle extraction check before sealing and rejection
systems are available as an option available as an option
• Capping system design reduces • Compliance with FDA 21 CFR Part 11
contamination to a minimum available as an option
• Machine is easily accessible for the
convenience of cleaning
• Simple and efficient format changes
www.romaco.com
2017 / 05