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The word parenteral comes from Greek and means outside the intestine (para=outside and enteron=intestine). In fact, when it comes to paranterals, 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.

What parenterals equipment do you need?

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...

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...

Brand protection software

Efficient security systems are desirable to prevent, detect and mitigate the actions of unscrupulo...

Semi-automatic case packer

Pharmaceutical products require complete traceability throughout the production cycle. For smalle...

Serial Data Managing Database

Managing serialization data is a vital part of accurate reporting and product integrity in the...

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 ...

Vacuum mixer for suspensions

The production of high quality pharmaceuticals often requires mixing of suspensions and similar...

Shell and tube heat exchanger

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

Stand-alone aggregation station

The aggregation of pharmaceutical products for tracking purposes is already compulsory in ma...

Serialization coding and labeling equipment

In the pharmaceutical industry, product serialization is the cornerstone of al...

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...

Feeder with flexible wall hopper

The varying properties of dry powder products mean that specialized feeders are required fo...

Small feeder with flexible wall hopper

In many laboratory applications and production processes, smaller quantities of powd...

GMP laboratory freeze dryer

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

Magnetic agitator

Reliable mixing and agitation are essential to any quality production process that involves a fluid. This n...

Flexible automatic inspection machine for ampoules, vials or cartridges

If you are looking to improve the efficiency of...

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...

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 ...

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...

Economic dispersing machine for emulsions and suspensions

For products of medium viscosity and relatively consistent par...

Ultra-fine dispersing machine for emulsions and suspensions

Producing the finest micro-emulsions and suspensions require...

Pilot dispersing machine for testing and scale-up

Innovators in process development need laboratory equipment that helps ...

In-line laboratory dispersing machine

Innovators in a wide variety of industries need laboratory equipment on which process...

Laboratory dispersing machine for low-viscous masses

Laboratory mixers have not always been easy to work with.  Getting a...

Jet flow agitator for high-viscosity media

Processes including homogenization, dispersing, suspension, emulsification and ...

Agitator for medium viscosity media

Mixing fluids of medium viscosity for many production processes requires an agitator wi...

Agitator for low viscosity media

Reliably agitating fluids in open or pressure-less vessels in a laboratory or small scale p...

Aseptic liquid filler for vials

Compact modular aseptic filler of vials with parenteral medicines and freeze-dried products.

Monobloc small volume liquid filler

These intermittent motion monobloc machines are designed for filling various liquids in...

High-speed small volume liquid filler

Fill liquid pharmaceutical, nutraceutical and cosmetic products in ampoules and bottl...

Case packer for cartons and bundles

Pack cartons and bundles into RSC (Regular Slotted Case) cases and perform functions li...

Stretch bander

A compact wrapping machine to seal your boxes with a max speed of 50 packs per minute.

Vertical cartoner

A cartoning solution that can be operated in either continuous or intermittent mode depending on the carton...

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.

Sterility test isolators

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

Small bottle checkweigher

Any small-diameter bottle, containing prescription medication or cosmetic applications, can be pro...

Versatile checkweigher

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

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Tell us about your production challenge

When selecting production equipment for a production plant, it is important to talk to someone with experience in your field. Our industry experts have experience with various industrial applications. We’d love to help you!
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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.

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