Tell us about your production challenge

Let's make parenterals

Find innovative production technology for making parenterals and connect directly with world-leading specialists.

Parenterals making equipment

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.

Which parenterals technology do you need?

Low speed Filler for large-volume parenterals

Low speed Filler for large-volume parenterals

Large-volume parenteral bottles are usually manufactured with a resin that ca…

Entry-level filler for large-volume parenterals

Entry-level filler for large-volume parenterals

Large volume parenterals are unit-dose containers that are larger than 100m…

Filling and closing machine for parenterals

Filling and closing machine for parenterals

Any pre-filled syringe can be filled and closed with this fast and easy machine…

Automatic forming and sealing blister machine for packing syringes

Automatic forming and sealing blister machine for packing syringes

Controlling contamination is on every manufacturer's …

Cold forming aluminum blister machine for capsules

Cold forming aluminum blister machine for capsules

Aluminum blisters are mainly used for packaging products that are sensi…

Reverse Osmosis water filtration system

Reverse Osmosis water filtration system

Reverse osmosis uses a partially permeable membrane to remove undesirable molecules,…

Horizontal cartoner for pharmaceutical applications

Horizontal cartoner for pharmaceutical applications

Automatic cartoning for cosmetic or pharmaceutical products is a requi…

?

Add your technology here

Do you have technology that can make this better? Tell us more!

Shell and tube heat exchanger

Shell and tube heat exchanger

Heating, cooling and tempering are important processes in the production of many products acros…

Sterile compounding system

Sterile compounding system

Hospitals and compounding centres have traditionally used manual aseptic compounding processes. As…

Compounding aseptic isolator

Compounding aseptic isolator

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

Closed restricted access barrier system

Closed restricted access barrier system

Pharmaceutical production techniques often require isolation of compounds and chemic…

Nested syringe filling machine

Nested syringe filling machine

Increasingly, pre-sterilized Ready To Use (RTU) nested vials, cartridges and syringes are the …

Continuous pack cartoner

Continuous pack cartoner

High volume automatic cartoning is vital for large scale production of cosmetic or pharmaceutical pro…

Visual and HVLD inspection for ampoules, vials and cartridges

Visual and HVLD inspection for ampoules, vials and cartridges

Do you need to improve the efficiency and capability of you…

Semi-automatic inspection machine for ampoules, vials or cartridges

Semi-automatic inspection machine for ampoules, vials or cartridges

If you need to increase the efficiency of your manua…

Small automatic inspector for ampoules, vials, or cartridges

Small automatic inspector for ampoules, vials, or cartridges

Inspect small batch production of ampoules, vials, or cartri…

Flexible automatic inspection machine for ampoules, vials, cartridges

Flexible automatic inspection machine for ampoules, vials, cartridges

If you are looking to improve the efficiency of yo…

Flexible automatic inspection machine for syringes

Flexible automatic inspection machine for syringes

Manufacture of pre-filled syringes requires the highest quality inspect…

Compact H2O2 disinfection system

Compact H2O2 disinfection system

Dry fogging provides safe, effective microbiological cleaning of critical areas in biotech, …

Table top sterile filling line for injectables

Table top sterile filling line for injectables

Where a compact solution is required for filling vials for the injectables m…

Start-up sterile filling line for injectables

Start-up sterile filling line for injectables

For smaller-scale production of vials and syringes for the injectables market…

Sterile filling line for injectables

Sterile filling line for injectables

Sterile filling of liquids and powders for the pharmaceutical and cosmetic industries r…

Labeling machines for pharmaceutical bottles

Labeling machines for pharmaceutical bottles

Labels for ampoules, vials and bottles are typically applied at the end of the…

Should your technology be listed here?

Can your technology help make this product better?

Sign up
Pharmaceutical bottles inspection machine

Pharmaceutical bottles inspection machine

For the visual inspection of small to medium batch-sizes of vials, ampoules or bo…

Ampoule filling machine

Ampoule filling machine

Filling ampoules or vials with parenteral fluids are an essential matter for which you need to conside…

Versatile checkweigher

Versatile checkweigher

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

High-speed small volume liquid filler

High-speed small volume liquid filler

Fill liquid pharmaceutical, nutraceutical and cosmetic products in ampoules and bottle…

Negative pressure isolator

Negative pressure isolator

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

Biological safety cabinet class III

Biological safety cabinet class III

Specially designed for the handling of microbiological agents, when working with indigen…

Positive pressure isolator

Positive pressure isolator

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

Biosafety cabinet class II for cytotoxic medicines

Biosafety cabinet class II for cytotoxic medicines

For the manipulation of hazardous substances utilized during the prepar…

Microbiological safety cabinet class II

Microbiological safety cabinet class II

This handy device offers the most advanced features in product-operator protection a…

Compact horizontal laminar flow bench

Compact horizontal laminar flow bench

HEPA filtered horizontal laminar airflow (cross-flow) creates an optimized free space …

Horizontal laminar flow benches

Horizontal laminar flow benches

HEPA filtered horizontal laminar airflow (crossflow) creates an ISO 14644-1 (Class 5) work ar…

Vertical laminar flow cabinet

Vertical laminar flow cabinet

HEPA filtered vertical laminar airflow (down flow) creates an ISO 14644-1 (Class 5) work area a…

Too much choice? Don't worry, we got you!

Connect directly with world leading technology suppliers.

We will connect you directly with a technology specialist that has experience with your process.

Contact us

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

Let's talk about your project!

Tell us about your production challenge and connect directly with leading manufacturers worldwide
All your data is kept confidential