
Making Parenterals
Find innovative production technology for making parenterals and connect directly with world-leading specialists
The word parenteral comes from Greek and means outside the intestine (para=outside and enteron=intestine). In fact, when it comes to parenterals, we are referring to those dosage forms that are administered directly into the bloodstream using a hypodermic needle, avoiding going through the gastrointestinal tract. Using parenteral filling equipment, parenteral solutions are placed in containers such as vials, syringes, or ampoules.
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Keeping it up to standards – achieving sterility and pyrogen-free solutions
Like any pharmaceutical dosage form, parenterals must meet pharmaceutical quality standards to be considered safe for their intended use. Two main requirements for parenteral solutions are to be sterile and free from pyrogenic contamination. Processes include sterilizing of equipment and containers using sterile filterers and autoclaves or radiation, and depyrogenation, which uses depyrogenation tunnels to remove bacterial endotoxins and other pyrogens.
To ensure that sterility is achieved, methods such as direct inoculation, membrane filtration, bacteriostasis/ fungistasis (B/F), and vaporized hydrogen peroxide (VHP) ingress testing are used. These methods test the samples for any presence of aerobic and anaerobic microorganisms, assess the possible growth of microorganisms, and validate sterility results.

For pyrogen testing instead, there are a number of methods. One of them is the monocyte activation test (MAT). This method mimics human immune reaction by incubating monocytes with the test sample. If pyrogens are present, monocytes are activated and produce inflammatory molecules, cytokines, responsible for the reaction. These are detected using an immunological assay involving specific antibodies and an enzymatic color reaction.
The most common method for endotoxin testing is bacterial endotoxin testing (LAL test – limulus amoebocyte lysate test). This is an assay based on the lysate of amoebocytes from the horseshoe crab blood which reacts with bacterial endotoxins in a coagulation reaction. This method has a high sensitivity for the quantification of endotoxins but it does not detect non-endotoxin pyrogens.
Formulation challenges when making parenterals: from excipient compatibility to pH value
In addition to being sterile and pyrogen-free, parenteral preparations may need excipients that are biocompatible. These excipients are selected for their appropriate use such as making parenteral preparations isotonic with the patient’s blood to prevent hemolysis or damage to cells and tissues. They can be used to adjust the pH level of the solution and maintain product stability and solubility. Other functions include providing adequate antimicrobial properties for multidose preparations.

Solubility and stability of the substance must be consistent throughout the shelf-life of the parenteral solution. For poorly soluble substances, you can use co-solvents, surfactants, or a solubility enhancer. The pH value is another critical aspect of parenteral preparations, which should be as close to physiological levels (between 3.0 to 9.0) to avoid tissue damage when the substance is injected into the body. This is why a pH buffer may be necessary to adjust the pH level of the substance. Note that large volume preparations (greater than 100 mL) should not contain a pH buffer as blood provides a buffer effect that could compete with the injected product.
Parenteral filling equipment in an aseptic environment
Parenterals are filled in ampoules, vials, syringes, cartridges, bottles, and bags. The entire process must be done under aseptic environment conditions to avoid contamination in which producers need to sterilize containers before the filling process. Isolators are placed around filling machines to separate the processing area from the environment combined with an automated sanitization system using hydrogen peroxide to decontaminate the area.

Parenteral filling equipment uses different technologies. One such technology is blow-fill-seal which is based on forming the container from heated polymer, filling it immediately after cooling and sealing it without involving contact with another product part. Another technology is closed-vial, based on the concept of using a sterile closed container. It is filled by a needle piercing the stopper and dispensing the liquid. After filling, the stopper is resealed using a laser.
Processing steps involved in parenterals making

Aseptic filling equipment

Bioreactor systems

Biosafety cabinets

Biotech

Blister Packaging Equipment

Capping

Cleaning

Contained transfer systems

Containment

Containment isolators

Downflow booths

Drying

Filling

Filtration

Flexible containment solutions

Freeze dryers

High pressure homogenizers

High-shear mixers

Inspection

Mixing

Monolithic columns

Packing

Single use systems

Sterilization
Which parenterals technology do you need?

Single-use mixing solutions for downstream processes
Designed for safe and efficient one-time use, this mixing solution e...

Vacuum filtration for sterile media and buffer preparation
Achieve reliable sterilization and filtration of cell culture...

Sterility testing consumables, media & instruments
Ensure your products meet sterility standards with advanced testing to...

Vial filling and stoppering for aseptic liquid or lyo products
Ensure optimal aseptic conditions in your production line...

Rotary vial filling and stoppering
Ensure precise liquid formulations and lyophilized product consistency with a high-speed...

External washing and drying system for ampoules and vials
Optimize your aseptic processing by seamlessly integrating a c...

Aseptic ampoule filling and sealing solution
Ensure precise dosing and secure sealing of sterile liquid pharmaceuticals in...

Depyrogenation tunnels for pharmaceutical containers
Ensure precise sterility and safety in pharmaceutical production wit...

Vial capping for small volume parenteral
Ensure precise sealing and contamination-free environments for small volume parent...

Automated headspace inspection system for parenteral containers
Ensure the integrity of pharmaceutical containers by pre...

Automated headspace inspection for parenteral containers
Ensure the integrity and quality of pharmaceuticals by inspectin...

Carbon dioxide headspace analyzer for parenteral containers
Ensure accurate headspace gas analysis to maintain container...

Oxygen headspace analyzer for container closure integrity testing
Ensure the integrity of oxygen-sensitive products wit...

Rotary vial washers for parenteral containers
Ensure sterile and pyrogen-free parenteral preparations with a seamless wash...

Small-scale freeze dryer for pharmaceutical applications
Optimize small-batch and pilot-scale lyophilization with advance...

Aseptic filling and stoppering solution for vials
Ensure precise aseptic filling and stoppering of vials with enhanced fl...

Depyrogenating tunnel for glass containers
Ensure the sterility of injectable medications by achieving reliable endotoxin ...

Injection stretch blow moulding line for pharmaceutical solutions
Optimize sterile solution production by forming, fill...

Optical inspection system for large parenteral containers
Ensure the quality and safety of liquid pharmaceutical product...

Sterile and nonsterile filling for injectable solutions
Efficiently fill and stopper injectable solutions in both sterile...

Optical inspection for pharmaceutical bags
Ensure flawless quality in your production line with high-speed optical inspect...

Bag forming system for pharmaceutical industry
For fluid pharmaceutical production, ensure precise formation and sealing o...

Reusable containers for sterile and toxic material transfer
Ensure safe and contamination-free transfer of sterile and t...

Superheated water sterilizer for large volume parenterals
When sterilizing large volumes of liquid products, achieving p...

Steam air sterilizer for aqueous solutions
Overcome the pressure challenge in sterilizing aqueous solutions, effectively p...

Liquid dispensing isolator for sterile environments
Maintain product sterility by utilizing a liquid dispensing isolator ...

Purified water generation system for pharmaceutical applications
Ensure consistent water purity for critical drug formul...

Radiopharmaceutical synthesis module
Ensure sterility and precision in radiopharmaceutical production with this versatile m...

Automatic aseptic filling line for Iv bags
Ensure aseptic integrity and high-speed processing of IV bags with a filling li...

Synthesis and dispensing hot cell for radiopharmaceuticals
Ensure precise synthesis and dispensing of radiopharmaceutica...

Ampoule filling and closing system
Optimize your production line with a high-speed system designed for seamless filling and...

Tabletop vial and syringe filling system
Ensure precise dosing and maintain sterility in small batch production with a comp...

Autoclave for sterilizing medical instruments and containers
Achieve reliable sterilization for a wide range of medical ...

Superheated water sterilization autoclave for pharmaceutical applications
Ensure precise sterilization of sensitive li...

Process analytical technology for lyophilization
Ensure product integrity by detecting trace contaminants and optimizing l...

Online moisture control for lyophilized pharmaceutical products
Ensure precise moisture control in lyophilized products ...

Syringe needle inspection module for pre-filled syringes
Ensure precise needle geometry with high-speed X-ray inspection,...

Lab headspace analyzer for small volume parenterals
Enhance your quality control with precise gas concentration measureme...

Headspace analyzer for small volume parenterals
Ensure precise gas concentration measurements in sterile pharmaceutical pa...

Headspace analyzation for small volume parenterals
Achieve unparalleled precision in gas concentration measurement for sm...

Automated container closure integrity tester
Ensure the integrity of your sterile pharmaceutical containers with high-spee...

Automated Cci tester for primary packaging containers
Ensure the integrity of pharmaceutical packaging with precise and n...

Non-destructive headspace analyzer for pharmaceutical packages
Ensure non-destructive and accurate headspace analysis fo...

Automated headspace analyzer for small volume parenterals
Optimize container closure integrity with high-speed, non-dest...

Automated headspace analysis for small volume parenterals
Ensure the integrity and quality of parenteral packaging with ...

Automated visual inspection for small volume parenterals
Ensure the integrity of high-value parenteral drugs by detecting...

Combined Avi and Cci tester for vials
Ensure comprehensive quality control of parenteral products with an integrated soluti...

Combined visual and container closure integrity testing for vials
Ensure the integrity and quality of parenteral packag...

Combined visual and container closure integrity tester for vials
Ensure precise quality control of pharmaceutical packag...

Accurate pharmaceutical dispenser for high-viscosity fluids
Achieve precise liquid dosing with ease, designed to handle ...

Robotic sterilization logistics system
Ensure seamless aseptic transfers across production stages with this robotic logisti...

Gravity rotary filling for large infusion bottles
Ensure precise filling and secure stoppering of large infusion bottles ...

Non-pvc film large infusion compact line
Streamline your infusion production with a compact line designed for high-speed, p...

Industrial freeze dryer for pharma
Optimize moisture removal in lyophilized products with precise thermal conduction and ef...

Steam & air mixture sterilizer for parenteral solutions
Achieve robust and effective sterilization for delicate pharmaceu...

Superheated water shower sterilizers for parenteral solutions
Optimize sterilization cycles for liquid pharmaceuticals w...

Sterile lyophilization for oncology pharmaceuticals
Optimize the sterility and stability of high-potency drugs with advan...

Sterilization chambers for medical device sterilization
When safeguarding medical devices and biopharmaceuticals, achievi...

Sterile lyophilised filling line
Ensure precision in filling and sterilization with an integrated system designed for stream...

Sublimation front monitoring system for freeze drying
Ensure precise control over your freeze-drying process with real-ti...

Modular pharmaceutical formulation systems
Achieve unparalleled flexibility and efficiency in liquid pharmaceutical formul...

Syringe filling line for parenteral drugs
Ensure precise dosage and sterility with this high-speed syringe filling line, i...

Automated visual inspection for pharmaceutical products
Ensure the integrity and safety of your parenteral products with ...

Wireless temperature sensors for lyophilization
Enhance your lyophilization workflow with precise, real-time temperature m...

Flow-through cell dissolution testing with Uv analysis
Effortlessly monitor real-time dissolution with flow-through cell ...

Non Pvc soft bag form fill seal system
Efficiently form, fill, and seal non-PVC infusion bags while ensuring precision and ...

Intelligent pre-filled syringe production line
Optimize your sterile liquid medication production with a streamlined pre-f...

Single-use transfer and filling solutions in barrier isolated filling lines
Ensure sterile, high-volume liquid transfe...

Sterile filling platform for pharmaceuticals
Achieve precise, high-speed aseptic filling and packaging with advanced compl...

Semi-automatic filling solution for syringes and vials in isolators
Achieve precise aseptic fill-finish operations for ...

Automatic forming and sealing blister machine for packing syringes
Controlling contamination is on every manufacturer...

Cold forming aluminum blister machine for capsules
Aluminum blisters are mainly used for packaging products that are sens...

Low speed Filler for large-volume parenterals
Large-volume parenteral bottles are usually manufactured with a resin that c...

Entry-level filler for large-volume parenterals
Large volume parenterals are unit-dose containers that are larger than 100...

Compact H2O2 disinfection system
Dry fogging provides safe, effective microbiological cleaning of critical areas in biotech,...

Reverse Osmosis water filtration system
Reverse osmosis uses a partially permeable membrane to remove undesirable molecules...

Ampoule filling machine
Filling ampoules or vials with parenteral fluids are an essential matter for which you need to consid...

Continuous pack cartoner
High volume automatic cartoning is vital for large scale production of cosmetic or pharmaceutical pr...

Horizontal cartoner for pharmaceutical applications
Automatic cartoning for cosmetic or pharmaceutical products is a requ...

Start-up sterile filling line for injectables
For smaller-scale production of vials and syringes for the injectables marke...

Table top sterile filling line for injectables
Where a compact solution is required for filling vials for the injectables ...

Shell and tube heat exchanger
Heating, cooling and tempering are important processes in the production of many products acro...

Nested syringe filling machine
Increasingly, pre-sterilized Ready To Use (RTU) nested vials, cartridges and syringes are the...

Closed restricted access barrier system
Pharmaceutical production techniques often require isolation of compounds and chemi...

Compounding aseptic isolator
Bespoke aseptic isolators designed for production environments don’t meet the needs of small-sc...

Sterile compounding system
Hospitals and compounding centres have traditionally used manual aseptic compounding processes. A...

GMP laboratory freeze dryer
Freeze dryer designed for aseptic and small-scale production of high-value products.

Purified water systems
Highly Purified water is used in the preparation of medicinal products where bacterial endotoxins need...

Flexible automatic inspection machine for ampoules, vials, cartridges
If you are looking to improve the efficiency of y...

Flexible automatic inspection machine for syringes
Manufacture of pre-filled syringes requires the highest quality inspec...

Small automatic inspector for ampoules, vials, or cartridges
Inspect small batch production of ampoules, vials, or cartr...

Semi-automatic inspection machine for ampoules, vials or cartridges
If you need to increase the efficiency of your manu...

Visual and HVLD inspection for ampoules, vials and cartridges
Do you need to improve the efficiency and capability of yo...

Filling and closing machine for parenterals
Any pre-filled syringe can be filled and closed with this fast and easy machin...

Multipurpose and R&D freeze dryer
A multipurpose unit in the research and development field. Some of the most common applic...

Sterile filling line for injectables
Sterile filling of liquids and powders for the pharmaceutical and cosmetic industries ...

Negative pressure isolator
Used for products biologically hazardous, that also require minimized cross contamination.

Downflow booth
Provides the highest levels of operator protection from potentially harmful airborne contaminants generated dur...

Vertical laminar flow cabinet
HEPA filtered vertical laminar airflow (down flow) creates an ISO 14644-1 (Class 5) work area ...

Horizontal laminar flow benches
HEPA filtered horizontal laminar airflow (crossflow) creates an ISO 14644-1 (Class 5) work a...

Compact horizontal laminar flow bench
HEPA filtered horizontal laminar airflow (cross-flow) creates an optimized free space...

Microbiological safety cabinet class II
This handy device offers the most advanced features in product-operator protection ...

Biosafety cabinet class II for cytotoxic medicines
For the manipulation of hazardous substances utilized during the prepa...

Positive pressure isolator
Ideal for products which have no biological risk but require high sterile conditions.

Biological safety cabinet class III
Specially designed for the handling of microbiological agents, when working with indige...

Labeling machines for pharmaceutical bottles
Labels for ampoules, vials and bottles are typically applied at the end of th...

Pharmaceutical bottles inspection machine
For the visual inspection of small to medium batch-sizes of vials, ampoules or b...

High-speed small volume liquid filler
Fill liquid pharmaceutical, nutraceutical and cosmetic products in ampoules and bottl...

Compact laboratory freeze dryer
Particularly suitable for research centers requiring greater freeze drying capacity. Some of...

GMP freeze dryer
Designed to perform clinical trials, pilot, and small scale or large scale industrial drying processes, in ac...

Custom engineered freeze dryer
For either bulk format or liquid in vials, ampoules or syringes, the Lyomega units are design...

Pilot freeze dryer for scale up
Designed for biological, pharmaceutical and food products formulation and “scale up...

Superheated water shower autoclave
Specially designed for sterilizing large batches of parenteral solutions.

Steam and air mixture sterilization autoclave
Specially designed for sterilizing large batches of parenteral solutions.

GMP autoclave
When sterilizing and dealing non-thermolabile products, you will want to get a hold of those resistant to the te...

Dry heat depyrogenation oven
Specially designed for the drying and sterilization of glass containers, vials or ampoules, and...

Sterility test isolators
Designed to avoid this risk and protect the product from both the process and externally generated f...

Versatile checkweigher
This Versatile checkweigher is equipped with a highly versatile strain gauge load cell. It is also sui...