
Let's make parenterals
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...

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 ...

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...

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...

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

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 ...

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. Â 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...

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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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 equipment

Blister packing equipment

Contained transfer systems

Containment isolators

Containment technology

Dispersing equipment

Downflow booths

Fill level inspection

Flexible containment solutions

Freeze dryers

High pressure homogenizers

High-shear mixers

Industrial inspection equipment

Labeling machines

Mixing equipment

Monolithic columns

Packaging equipment

Single use systems
