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 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
Entry-level filler for large-volume parenterals
Low speed Filler for large-volume parenterals
Compact laboratory freeze dryer
Pilot freeze dryer for scale up
Multipurpose and R&D freeze dryer
Custom engineered freeze dryer
GMP freeze dryer
GMP autoclave
Steam and air mixture sterilization autoclave
Superheated water shower autoclave
Dry heat depyrogenation oven
GMP laboratory freeze dryer
Purified water systems
Downflow booth
Sterility test isolators
Vertical laminar flow cabinet
Horizontal laminar flow benches
Compact horizontal laminar flow bench
Microbiological safety cabinet class II
Biosafety cabinet class II for cytotoxic medicines
Positive pressure isolator
Biological safety cabinet class III
Negative pressure isolator
High-speed small volume liquid filler
Versatile checkweigher
Ampoule filling machine
Pharmaceutical bottles inspection machine
Labeling machines for pharmaceutical bottles
Sterile filling line for injectables
Start-up sterile filling line for injectables
Table top sterile filling line for injectables
Compact H2O2 disinfection system
Flexible automatic inspection machine for syringes
Flexible automatic inspection machine for ampoules, vials, cartridges
Small automatic inspector for ampoules, vials, or cartridges
Semi-automatic inspection machine for ampoules, vials or cartridges
Visual and HVLD inspection for ampoules, vials and cartridges
Continuous pack cartoner
Nested syringe filling machine
Closed restricted access barrier system
Compounding aseptic isolator
Sterile compounding system
Shell and tube heat exchanger
Horizontal cartoner for pharmaceutical applications
Reverse Osmosis water filtration system
Cold forming aluminum blister machine for capsules
Automatic forming and sealing blister machine for packing syringes
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Select your parenterals process
Tell us about your production challenge
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.