Products

Modular Process Skids

Modular process plants for the formulation and production of pharmaceutical and biotechnology products (vaccines, antibiotics, insulin, plasma, suspensions, syrups, injectables, aerosols, cytotoxic, etc.).

We have more than 40 years of experience in the design, building, installation, and validation of turnkey process plants with integrated automatic control systems.

All modular process skids are built according to the most recent GEP, ASME, FDA, cGMP, and GAMP regulations and can be customized according to customer requirements.

We provide customer support throughout the lifespan of the equipment, including after-sales support with the supply of spare parts and software service with qualified personnel to prevent production plant shutdowns.

Product Lines

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Blood Plasma

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Biotech Modular Super Skids

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Parenteral Formulation Compounding

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Syrup and Suspension

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Transfer Panels

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.

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.

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.

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