Products
Process Skids
Process plants for the formulation and production of pharmaceutical and biotechnology products (vaccines, antibiotics, insulin, plasma, suspensions, syrups, injectables, aerosols, cytotoxic, etc.).
With over 40 years of industry-leading experience, we are proud to offer turnkey solutions that encompass everything from design and building to installation and validation, all with the convenience of fully-integrated automatic control systems.
Each of our process skids is built in compliance with the most recent and stringent regulations, including GEP, ASME, FDA, cGMP, and GAMP, ensuring both safety and quality. We understand that every customer has unique needs, which is why we offer complete customization options to meet your specific requirements.
We are dedicated to helping our customers throughout the lifespan of their equipment. Our skilled team offers complete customer service, from installation to after-sales support. We provide spare parts and software services to prevent any potential production plant shutdowns.
Product Lines
Biotech Modular Super Skids
Blood Plasma
cream, gel and suppository
cytotoxic anticancer
Insulin
Parenteral Formulation Compounding
SPRAY AEROSOL OPHTHALMIC
SYRUP AND SUSPENSION
VACCINES
Biotech Modular Super Skids
Process skid modules for the manufacturing of liquid products for the pharmaceutical and biotechnology industries.
Process equipment mounted within a large steel frame
The modular system has many advantages. Tanks, pumps, filters, heat exchangers, control or regulating valves, and the complete metering technology are put together as a module on a frame or “skid.” The maximum dimensions are essentially limited only by the size of the vehicle to be used to transport it, or the dimensions of the entrance it must pass through to enter the building.
This modular approach is an ideal application to defer the fabrication of complex piping and instrumentation to an environment where there is close proximity to tools, materials, and external resources.
Why choose the skid module approach?
- Designed from both a mechanical and an electrical point of view, as standalone sub-systems
- Reduces field activities at site
- Reduces overall timeline
- Reduces interference with other field contractors
- Test all functionality prior to coming into the site
- Minimizes field re-work
- Quality of skid construction execution
- Vendor as single point of accountability and point of integration of all aspects of equipment delivery
- Cost control; Lump sum vs time/material
- Commissioning and on-site tests are reduced to a minimum, since all the plant components remain on the skid.
3D skid model
- 3D models are reviewed by an integrated team (engineering, production, maintenance, construction quality) to challenge as many issues as possible before construction
- Interference with site (electrical, HVAC, piping)
- Design transportability of skid without impacting commissioning activities.
blood plasma
The fractionation process is based on the different solubility of plasma proteins with respect to the following parameters: chemical and physical ethanol concentration, temperature, pH, and ion strength. To get homogeneity in batches of donated plasma and to reduce the risk of viral transmission before definitive release for packaging, plasma products always undergo several virus inactivation steps (depending on the final product) such as:
- Pasteurization
- Heating of freeze-dried products
- Detergent solvent treatment
- Nanofiltration
- Low pH
- Chromatography
- Sterile filtration
Afterwards, many different separation steps could follow:
- Cryo-precipitation
- Ion exchange chromatography
- Affinity chromatography
- Alcohol precipitation
- precipitation
- PEG precipitation
- Centrifugation
- Ultrafiltration
- Partitioning through filter press
Different plasma-derived products can be obtained from plasma fractionation.
An automatic or semi-automatic control system supervises each process recipe or maintenance phase; the system allows the customer to monitor and record all process parameters, both critical and non-critical. This can guide the operator in each process operation and become a batch record which is visible on the Operator Panel.
- Fibrin glue
- Fibrinogen
- Von Willebrand’s Factor
- Fraction V
- Albumin
- Fraction IV
- Immune-globulin
- Fraction II+III
- F XIII
- Fraction I
- F XI
- F VII
- AT III
- Protein C
- F IX
- F VIII
The conditions under which all plasma fractionation steps take place are very important; for example, the temperature of buffer addition in precipitation tanks, the pH of suspension before each filtration or centrifugation, and the optical density of permeate during the Albumin Ultrafiltration, etc.
Efficiency is achieved by our advanced manufacturing concepts for vessels and valve technology. The piping shall strictly comply with the capacity and heating and cooling system parameters, and the proper CIP/ SIP engineering must be up to an organic material treatment plant to prevent rapid bacterial growth.
cream, gel and suppository
Cream, gel and suppository plants have to handle high viscosity products
To produce a consistently stable product, engineers must carefully consider both the physical characteristics of the product and the interaction between different ingredients. This requires designing a plant that can effectively handle these factors, which commonly involves equipping it with top-mounted agitators and high-speed homogenizers.
Manufacturing Process
In the complex manufacturing process of pharmaceuticals, one of the most critical components is the Temperature Control Module, which plays a crucial role in melting excipients and adding the Active Pharmaceutical Ingredient (API). This module maintains a stable temperature and provides precise temperature control, making it indispensable to ensure high-quality, consistent products. To maintain vessel and distribution piping cleanliness, a Clean-In-Place (CIP) station equipped with the capability to add acid and base is essential, making it an ideal addition to any pharmaceutical manufacturing plant.
While the production of solid dosage forms involves melting a base made of excipients and adding active ingredients before allowing the compound to cool, creams pose several manufacturing challenges. These challenges include agglomerations, clumps, and unstable emulsions. By having the appropriate equipment in place, such as temperature control modules and CIP stations, the production of high-quality creams becomes possible. These equipment ensure that the manufacturing process is consistent, clump-free, and stable, ultimately leading to the creation of consistent, reliable, and efficacious pharmaceutical products.
The Suppository Plant is designed to be a convenient and easy-to-use model. It comes fully pre-assembled and cabled in the workshop and can be operational at the customer’s site immediately.
The plant consists of several components, including :
- 750 L homogenizer fixed tank jacketed
- Heated loop to the filling line
- Stainless-steel skid
- Temperature control unit
- Rotor/stator homogenizer with an AISI 316L impeller
- Anchor mixer for high product viscosity
- Load cell weighing system, and a CIP SKID (which is a stand-alone unit).
A compliant automation system can be designed based on modular PLCs that interface with I/O devices and meet the requirements of GAMP 5 and FDA 21 CFR Part 11. The plant can also have multiple HMI and be managed through a full SCADA system for functions such as recipe management, batch management, data storage, and reporting.
- 822 TAG
- 77 welding
- 85 I/O
- 21 valves
- 16 pumps
- 215 m of piping and fittings
- 1106,5 engineering hours and detailed design
- 730,5 hours of electrical design
- 71 hours of FAT
- 301,5 hours for Documentation activities
CYTOTOXIC ANTICANCER
Cytotoxic drugs operate by impeding or preventing the functionality of cells, thereby inhibiting their replication or growth. These drugs are primarily used in the treatment of cancer and other related disorders. Due to the inability of this drug category to specifically target tumorous cells, healthy cells may also be affected, leading to potential side effects in patients as well as operators who may be exposed to them.
Compounding and dispensing isolator
The isolator plays a vital role in cytotoxic processing plants. As a specialized system designed to manage liquids containing cytotoxic compounds, it provides an effective barrier that shields operators, products, and the environment from hazards arising from the uncontrolled diffusion of air-transported contaminants. The incorporation of isolators in the design of cytotoxic processing plants is crucial to ensuring the highest level of safety for all involved.
Customized Automation System
The plant can be efficiently managed through an automation system that oversees various functions such as monitoring operation modes, manual controls, general parameter management, alarm management, interlocking, batch management, data management, and more.
The plant boasts a sophisticated design that allows for seamless production through its subdivision into five distinct blocks, each corresponding to a specific phase of the process.
The first block focuses on excipients production, encompassing the creation of a salty solution and sucrose. Moving on to the second block, the lipids production takes center stage, with cutting-edge extrusion and diafiltration systems utilized to generate the lipidic component of the liposome.
Block three, the API loading zone, is a highly secure area where operators can safely load the active principle through an isolator, accessed only via glove ports. In the fourth block, the heating and cooling systems take charge, shaping the liposome into the ideal delivery system for the drug.
The final block, comprised of a filtration group and sterile holding tank, is instrumental in maintaining the sterility of the final product. Once the process is complete, the product is smoothly transferred to the filling line.
Details:
- 2608 TAG
- 2980 Welding
- 1050 I/O
- 3725,5 engineering hours
- 682 hours for detailed design
- 128,5 hours for Documentation activities.
INSULIN
Biosynthetic production of human insulin predominantly employs bacteria, whose fermentation begins in culture broth. However, a breakthrough in recombinant DNA technology has led to the production of lispro insulin in plants, which closely resembles the insulin naturally produced by the beta cells in the human pancreas.
With only a minor difference in structure, the synthetic lispro insulin allows for a rapid absorption and increased efficacy, enabling more efficient management of diabetes. The versatile administration options of subcutaneous injection, continuous subcutaneous infusion via an external pump, and intravenous delivery offer patients flexible and personalized treatment choices.
The Insulin Plant is fully compliant with PED, CEI, cGMP, cGEP, FDA, GAMP regulations and produces a five-digit number batch of 3 ml insulin cartridge each hour.
The plant consists of four formulation tanks with stations, four filtration lines, two sterile receivers, two portable tanks, nine temperature control modules, and two CIP skids for cleaning and sterilization.
Three solutions, labeled Solution 1, Solution 2, and Solution 3, are held in 100L portable tanks on a floor scale and pumped through peristaltic pumps to three 500L portable tanks. These solutions are then transferred via a formulation transfer panel and pre-filtered before passing through sterile filters. Once filtered, they are moved to a 2500L sterile receiver. Before moving to the filling lines, samples are taken and tested using an optical density sensor.
Details:
- 5543 I/O
- 316 TAG
- 4 km of piping and fittings
- 1352 valves and similar
- 117 pumps
- 595 engineering hours
- 3 hours of detailed design
- 5 electrical design hours
- 829 hours of FAT and I/O tests
- 910 packing hours
- 1034 hours for Documentation activities
Parenteral Formulation Compounding
Modular process skids for parenteral formulation compounding. Custom designed and built according to your process conditions.
Common features for parenteral applications
- Fully drainable & crevice free design
- Minimization of product losses using block valve
- Use of aseptic sampling device
- Minimization of product sedimentation
- Flush mounted tank sanitary clamp – TK connect mounted on the top head of the tank
- Suitable for in-line CIP and SIP
- Fittings according to ASME BPE
High-Tech Components
The system design for high-quality production of parenterals and bioprocessing applications typically include both Clean-In-Place (CIP) and Steam-In-Place (SIP) requirements. CIP and SIP operations are complementary. Good cleaning is essential to the SIP operation because it removes residuals that could harbor microbes from steam contact during sterilization. Conversely, sterilization is often required prior to CIP to deactivate biohazards in the equipment. The use of parallel design requirements for CIP and SIP lead to an integrated solution that results in an optimized equipment design.
Design, construction, and validation for sterile processing
All equipment is designed and built according to specifications & requirements for sterile design following cGMP and GEP. ACIC Machinery offers a wide range of solutions, from individual pieces of equipment to complete integrated plants.
The systems can be supplied as Built-In-Place or as ready-to-use process modules. Ready-to-use or “plug & play” process modules can be supplied as pre-tested in a FAT, pre-IQ or pre-OQ. This type of pre-tested modules gives the client great advantages, reducing the total condition time of green field projects considerably and minimizing downtime during installation of new modules in existing process lines.
Automation
Injection solution / Infusion solution / Suspension / Ophthalmic solution / Parenteral solution / Coating solution
System control options range from simple, manual push-button control to fully programmable logic controller (PLC) based SCADA options offering a wide range of recipe handling, data acquisition and networking functions. The system complies with all current industry standards and standard communication ensures full compatibility with existing control strategies and plant-wide supervisory systems.
SPRAY AEROSOL OPHTHALMIC
Manufacturing Process
The manufacturing process is a complex series of critical steps that require careful consideration. These steps include dispensing, formulation, sterile filtration, crystallization, final mixing, aseptic filling, sorting and inspection, and release testing. To ensure optimal performance, each plant is custom designed to meet the unique requirements of the customer’s User Requirement Specification (URS).
Insulin plants are specifically designed with a fixed number of formulation tanks and related stations, filtration lines, sterile and fixed receivers, Temperature Control Modules, and C.I.P. skids for efficient cleaning and sterilization of the entire plant.
In addition, the plants are equipped with intermediate portable tanks of various sizes to facilitate multiple uses and preparation steps, providing flexibility in the manufacturing process. Overall, the manufacturing process and plant design are carefully crafted to meet the highest standards of quality and efficiency.
High Standards:
- Automated Insulin Plants which are fully compliant with PED, CEI, cGMP, cGEP, FDA, GAMP, GAMP5 regulations
- The technical team can design compact systems or large and flexible plant that can produce batches of insulin cartridges in the five-digit range per hour.
Syrup and Suspension
Syrup and Suspension preparation are typically designed with the same high-quality standard as applied for sterile processes. Every detail of the design must meet high quality standard demands, to reduce validation requirements.
All equipment is designed and built according to specifications & requirements for sterile design following cGMP and GEP. ACIC Machinery offers a wide range of solutions, from individual pieces of equipment to complete integrated plants.
Syrup and Suspension
Syrup is produced by blending water, sweeteners, flavor concentrates, and other ingredients. The most common sweetener is sugar. Simple syrup is made by dissolving crystalline sugar, adding flavor and other ingredients, then filtering to the storage tank. An aqueous suspension preparation comprises of a water-insoluble local anesthetic and/or narcotic analgesic in the form of particles.
The preparation is to be used within a relatively brief time, otherwise sedimentation and agglomeration of the particles of the active agent will begin which can lead to clogging of injection needles or injection catheters.
Features for Syrup and Suspension
- Fully drainable, crevice free design
- Minimization of product loss using block valve
- Use of aseptic sampling device
- Minimization of product sedimentation
- Flush mounted tank sanitary clamp – TK connect – mounted on the top head of the tank
- Completely suitable for in-line CIP and SIP
- Use of air operated diaphragm pump
- Use of transfer panel
- Use of Tri-blender / homogenizer
Design, construction, validation for sterile processing
Through our knowledge of the latest components of valve technology we are capable of generating our clients’ designs using reasonable and appropriate requirements / criteria.
The systems can be supplied as Built-In-Place or as ready-to-use process modules. Ready-to-use or “plug & play” process modules can be supplied as pre-tested in a FAT, pre-IQ or pre-OQ. This type of pre-tested modules gives the client significant advantages by reducing the total condition time of green field projects considerably and minimizing downtime during installation of new modules in existing process lines.
Automation
System control options range from simple, manual push-button control to fully programmable logic controller (PLC) based SCADA options offering a wide range of recipe handling, data acquisition and networking functions. The system complies with all current industry standards and standard communication ensures full compatibility with existing control strategies and plant-wide supervisory systems.
Transfer Panels
Application
Transfer panels have become popular within the pharmaceutical and biotechnology industry because of their singular ability to accommodate multi-flow transfers, keeping the operator in safe conditions. A typical transfer panel is fabricated from a ¼ ‘ thick 304 / 316L grade stainless steel plate. Connections are welded to the panel front to mate with the port-to-port jumpers (or “U” bends). The ports are designed in a required process transfer sequence and located to precise tolerances.
Working principle
- Provide a common point to transfer a process stream from one process equipment or unit operation to another.
- Provide a physical disconnect when transferring various process streams. This reduces the possibility of cross-contamination especially under CIP conditions.
- The use of stainless-steel jumpers eliminates temporary connections such as flexible hoses which are difficult to maintain in a hygienic condition and can be a safety concern when steam sterilizing.
- Combination of jumpers and proximity switches on the panel provide permissive signals to the plant control system to confirm the correct set up of connections or “U” bends and assure the flow passages for critical operations such as C.I.P. and S.I.P.
Detail design panel / docking station
There are different types of transfer panels and workstation: some are leg-supported and ground-fixed, others are a steel wall integrated to the pharmaceutical wall, others look like integrated “panels” in the modular panel.
The modular panel design features integrated pre-piping, valve groups and instrumentation wiring at the back.
Transfer Panel construction for sterile processing
A traditional transfer panel consists of only the panel plate, the front ports, and the supporting legs. The piping connections in the back are usually short, weld open tube ends to be welded to the interconnecting piping in the end-user facility site.
- Design and fabrication of the piping assemblies allow a compact piping and valve arrangement, saving premium process piping space and orientating the piping, valve, and instruments to meet specific process or maintenance demands.
- We provide a single point of contact for all piping fabrication responsibilities and allow the customer and design engineers to review and inspect the fabrication throughout all project phases.
- Transfer panels with specific piping connection points simplify the field preparation and welding efforts and minimize potential mechanical interference problems.
Wide selection to meet your distribution needs
- PW / WFI load for processing tanks
- Transfer from a processing tank to a storage tank
- CIP – SIP – drain
- Filtering
Pre-assembling for utilities
- Clean utilities such PW / WFI / clean steam
- Industrial steam
- Compressed air
- Electric energy
VACCINES
Fermenter or bioreactor is a crucial element in industrial productions of vaccines.
- Fermenters are used in the upstream process, which involves obtaining the product used in mass production. The upstream process starts in the laboratory with a small-volume tank and gradually progresses to larger bioreactors.
- Choosing the appropriate fermenter depends on various factors, including the type, quantity, and characteristics of the desired product.
- A high-quality fermenter should be easily sterilizable, equipped with advanced aeration and agitation systems, and fitted with valves to enable precise control via sensors.
- Upon completion of the fermentation process, the downstream stage of product recovery begins. Typically, the microbial biomass is separated from the spent culture medium using centrifugation or filtration methods.
- In the vaccine production cycle, the fermenter serves as an intermediate step between laboratory cell culture and large-scale industrial production, facilitating a smooth and efficient scale-up process.
The fermenter has been designed in compliance with the ASME BPE, GEP, cGMP, and FDA standards. It comprises of the following components:
- A stainless-steel platform.
- A 1,200 L fermentation tank that has been tested and certified by the PED.
- Four seed tanks.
- Utility lines that need to be connected in the technical area.
- CIP and condensate discharge lines.
- A TCM that facilitates heating and cooling.
The fermentation tank is of the tank-in-tank type and is made of AISI 316. It has a flanged lid with a bolted closure. The seed tanks have capacities of 3, 4.5, 60, and 100 L respectively. These tanks feed the fermenter using overpressure. The fluid is loaded into the fixed tanks via peristaltic pumps in containers on scales.
The CIP and SIP modules ensure that the fermentation process maintains maximum cleanliness and sterility at all stages.
- 822 TAG
- 2516 welding
- 487 valves
- 685,4 m of piping and fittings
- 2785,5 engineering hours and detailed design
- 494,8 hours of welding
- 355 hours for Documentation activities
- 262,8 packing hours
- 100 assembling hours at customer’s site.
