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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 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 equipment do you need?

Filling and closing machine for parenterals

Any pre-filled syringe can be filled and closed with this fast and easy machin...

Entry-level filler for large-volume parenterals

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

Low speed Filler for large-volume parenterals

Large-volume parenteral bottles are usually manufactured with a resin that c...

Compact laboratory freeze dryer

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

Pilot freeze dryer for scale up

Designed for biological, pharmaceutical and food products formulation and "scale up" work.

Multipurpose and R&D freeze dryer

A multipurpose unit in the research and development field. Some of the most common applic...

Custom engineered freeze dryer

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

GMP freeze dryer

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

GMP autoclave

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

Steam and air mixture sterilization autoclave

Specially designed for sterilizing large batches of parenteral solutions.

Superheated water shower autoclave

Specially designed for sterilizing large batches of parenteral solutions.

Dry heat depyrogenation oven

Specially designed for the drying and sterilization of glass containers, vials or ampoules, and...

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...

Downflow booth

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

Sterility test isolators

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

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...

Negative pressure isolator

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

High-speed small volume liquid filler

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

Versatile checkweigher

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

Ampoule filling machine

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

Pharmaceutical bottles inspection machine

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

Labeling machines for pharmaceutical bottles

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

Sterile filling line for injectables

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

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 ...

Compact H2O2 disinfection system

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

Flexible automatic inspection machine for syringes

Manufacture of pre-filled syringes requires the highest quality inspec...

Flexible automatic inspection machine for ampoules, vials, cartridges

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

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...

Continuous pack cartoner

High volume automatic cartoning is vital for large scale production ...

Nested syringe filling machine

Increasingly, pre-sterilized Ready To Use (RTU) nested vials,...

Closed restricted access barrier system

Pharmaceutical production techniques often require ...

Compounding aseptic isolator

Bespoke aseptic isolators designed for production environments ...

Sterile compounding system

Hospitals and compounding centres have traditionally used manual ...

Shell and tube heat exchanger

Heating, cooling and tempering are important processes in the ...

Horizontal cartoner for pharmaceutical applications

Automatic cartoning for cosmetic or p...

Reverse Osmosis water filtration system

Reverse osmosis uses a partially permeable membrane to remove undesirable molecules...

Cold forming aluminum blister machine for capsules

Aluminum blisters are mainly used for packaging products that are sens...

Automatic forming and sealing blister machine for packing syringes

Controlling contamination is on every manufacturer's...
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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

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