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Pre-filled syringes containment Equipment

The essential objectives of containment systems are personnel protection and preventing the release of toxic or infectious material into the environment. Containment is also used to prevent a product or sample from contamination by the external environment. In the chemical and pharmaceutical industries, containment solutions are used to protect the personnel from the leaking of airborne particles of hazardous substances, as powders or liquids are handled or transferred during processing.

Containment

A pre-filled syringe or PFS is a single-dose disposable syringe that is supplied loaded with the substance to be injected. By using a pre-filled syringe filling machine, you can have excellent dosage accuracy due to the exact filling of medications. During administration, safety from potential contaminants is also ensured as they are directly injected after opening. To further minimize the risk of contamination, pre-filled syringes are often filled and sealed in a sterile environment using stainless steel equipment.

Pre-filled Syringes

Designed to avoid this risk and protect the product from both the process and externally generated factors that would compromise its quality.


<h2>Perform sterility testing in an aseptic environment providing assurance of material integrity</h2>
The Sterility test isolators from Telstar Life-Science range of rigid wall Sterility are designed to avoid this risk and protect the product from both the process and externally generated factors that would compromise its quality.

Sterility testing of sterile pharmaceutical products is required by the Pharmacopoeias to determine acceptability of a production lot. It is an essential element of sterilization validation and it must be performed in a manner which avoids the risks of both false positive and false negative results.

It is suitable for performing both Direct Inoculation and Filter Membrane sterility tests with flexibility to be bio-decontaminated by different types of bio-decontamination systems available.

Sterility test isolators

Transferring powders from drums to process equipment such as reactors or mills can create dusty and hazardous conditions in a manufacturing environment and can be a source of worker exposure to hazardous substances in the pharmaceutical and bioprocess industries. Experienced biopharmaceutical manufacturers know that equipment designed for general industry use often falls short and rigid containment and transfer solutions for the biotech industry are often awkward and inefficient. Producers that embrace flexible solutions designed specifically for the challenges of our industry will find an advantage over competitors.


<h2>Safely and easily empty powder drums without sacrificing containment</h2>
ILC Dover is an industry leader in contained material handling solutions for high-tech manufacturers and end users including NASA. The company's flexible contained drum transfer system allows operators to empty the powdered contents of drums used in the pharmaceutical and bioprocess industries without exposure to the contents. The contents are also protected from potential contamination during the transfer process using this equipment. A flexible containment chamber made from ILC Dover’s rugged Armorflex material is anchored to a raised stainless steel frame using ergonomic bungee cords. The containment chamber includes a discharge sleeve, a drum sleeve, and 2 glove sleeves for operator manipulation of the drum lid and internal liner under contained conditions. A closed drum is placed on the integrated pneumatic drum lift and the drum sleeve is attached. The discharge sleeve is attached to a ring in the frame designed to interface with downstream process equipment. The containment chamber is at a height off the floor which allows the powder to be gravity fed into downstream process equipment or containment solutions placed under it. The operator then raises the drum to the containment chamber with the simple actuation of a lever and opens the lid using the integrated glove sleeves. This manual interaction allows the operator to ensure that all powder flows out of the drum liner to the next process stage without being directly exposed to it. When the drum is empty, its spent liner is placed inside of it and its lid replaced. It is then lowered back to the floor and discarded. The sleeves in the flexible containment system are twisted closed and crimped off ensuring no powder contamination of the surrounding environment. The containment chamber is then discarded and the process repeated for each new drum to be transferred.

Flexible contained drum transfer system

Thermal and mechanical changes can lead to stresses in industrial piping systems. These stresses can be transferred to components causing misalignment and leakages. They may also cause inaccuracies in weighing and other sensitive measurements.


<h2><strong>Connect chutes and process equipment without pipe stress</strong></h2>
Andocksysteme offers a wide range of compensators and bellows to eliminate misalignment and stress-related issues. These components provide a reliable, stress-free connection between transfer chutes and process equipment with strict weighing requirements. They are ideal for transfer of powders in the pharmaceutical industry. A complete range of injection mold tooling allows Andocksysteme to produce compensators and bellows in the desired length and thickness.

The internal diameter of the compensator is matched to the diameter of the process-chute to eliminate difficult to clean crevices or ledges and allow effective WIP/CIP. Andocksysteme bellows and compensators offer a range of material hardness and connection standards. Material choices include FDA compliant white and black EPDM, Viton, silicone (on request) and FFKM / FFPM elastomers for particularly aggressive duties.

Bellows for pharmaceutical powders

Sterile filling of liquids and powders for the pharmaceutical and cosmetic industries requires flexible automation to accommodate format changes and optimize production. Also, vial sizes can range from 0.1 ml to 500 ml and syringes from 0.1 ml to 20 ml.
<h2>Fill, stop and crimp syringes and vials of all sizes</h2>
XI-I is specially designed by i-Dositecno for pharma filling, able to fill sterile liquid and powder in doses from 1 to 500 mls into vials and syringes.

4,000 units per hour can be produced for formats up to 80 mm diameter in a simple configuration, while 7,000 units per hour can be attained for smaller units up to 26 mm diameter in a double configuration.

Filling is by means of peristaltic pump, stainless steel rotary pump, ceramic rotary pump or CIP/SIP rotary pump. Stoppers are introduced by pick and place and capsule introduction and crimping are also completely servo driven.

&nbsp;

Sterile filling line for injectables

For smaller-scale production of vials and syringes for the injectables market, sterile conditions and accurate metering are still required for filling, stopping and crimping a wide range of container sizes.
<h2>Fill vials and syringes in basic, yet flexible, configuration</h2>
The i-Dositecno MI-I is specially designed for sterile pharma filling, able to fill sterile liquid and powder in doses from 1 to 500 mls into vials and syringes.

3,000 units per hour can be produced for formats up to 80 mm diameter in simple configuration, while 6,000 units per hour can be attained for smaller units up to 26 mm diameter in a double configuration.

Filling is achieved by means of peristaltic, stainless steel rotary, ceramic rotary or CIP/SIP rotary pump. Stoppers are introduced by servo-driven pick and place, however, capsule introduction and crimping heads are controlled by pneumatics.

&nbsp;

Start-up sterile filling line for injectables

Where a compact solution is required for filling vials for the injectables market, sterile conditions and high-quality metering still need to be maintained.
<h2>Space-saving fill, stop and crimp line for vials</h2>
The table top BI-I from i-Dositecno can fill sterile liquid and powders in doses from 1 to 500 mls into vials, as well as specialized micro-dosing.

It can produce up to 2.000 units per hour for injectable vials from 2R to 500H as well as install rubber stoppers ranging from 12 mm to 32 mm and alu-caps 12 mm to 32 mm in size.

Filling is achieved by means of a peristaltic pump or a servo auger filler for micro-dosing which can meter as little as 0.150g. Stoppers are introduced by pneumatic pick and place and alu-caps loaded by chute, with crimping performed by pneumatics.

&nbsp;

Table top sterile filling line for injectables

<span style="font-weight: 400;">Hospitals and compounding centres have traditionally used manual aseptic compounding processes. As well as being labour intensive, these also allow for the introduction of human error, both into dosing and mislabelling, and potential for breaching sterility. A 21st century automatic aseptic compounding system using robotic and RFID technology overcomes these problems at a stroke, increasing productivity, reducing lead times, and guaranteeing dosing accuracy and traceability.</span>
<h2>Complete robotic aseptic compounding system</h2>
<span style="font-weight: 400;">Steriline’s ACS Aseptic Compounding System is a computer-controlled system for compounding intravenous doses into IV or other containers within an ISO 5 environment. It has been designed for use in hospitals and compounding centres, and operates in accordance with all appropriate regulations, including labeling in accordance with industry “best practice” standards.</span>

<span style="font-weight: 400;">The ACS can handle both hazardous and non-hazardous medication, and can be used for both patient specific and batch production. Based around tried and tested Isolator technology, ACS includes vaporized hydrogen peroxide (VHP) sterilization as standard. This means it can be installed in an ISO 8 background environment, as per GMP Annex 11.</span>

<span style="font-weight: 400;">The ACS uses cutting edge automation and robotics technology to remove the need for human intervention to:</span>
<ul>
 	<li><span style="font-weight: 400;">Sterilize all items with (VHP) prior to compounding;</span></li>
 	<li>Calculate all conversions between weight and volume;</li>
 	<li>Reconstitute powder drugs with the appropriate fluid;</li>
 	<li>Dilute liquids to required concentrations;</li>
 	<li>Remove excess liquid from IV bags and bottles;</li>
 	<li>Compound doses into empty containers (including syringes, IV bags, and elastomeric infusors);</li>
 	<li>Manage in-process waste.</li>
</ul>
<span style="font-weight: 400;">Safety is paramount, and the Steriline ACS features a raft of features to ensure environmental, operator and patient safety, including ISO5 isolator technology; access restriction systems; zero cross-contamination risk operation; complete identification of all items via combination of vision, RFID and barcode systems; guaranteed traceability.</span>

Sterile compounding system

Users who prefer rigid storage over single-use pharma charge bags, require lightweight solutions for easy handling, especially when storing and transferring active pharmaceutical ingredients. The containers must clamp securely to equipment to ensure no powder loss or cross-contamination and make efficient use of space when stored.
<h2>Bottles for Convenient Storage and API Powder Transfer</h2>
Ezi-Dock pharma process bottles were designed to be used with Split Butterfly Valves. They have unique square design ensuring a more compact footprint per unit of storage in pharmaceutical and biopharmaceutical laboratories. Their filling and dispensing necks feature a standard 6-inch Tri-Clamp neck design that uses an injection-moulded adaptor to connect to laboratory equipment receiving the product.

These versatile containers are available in a variety of sizes including 15, 25, 30 and 40 litre capacity. Bottles are in individual cartons packed in quantities of 84, 60, 48, and 36 respectively for space-efficient storage. They are made of high-density polyethylene that is blow-moulded to comply with the U.S. Pharmacopeia standard.

API powders storage bottle

Pharma and biopharma laboratories need fast effective solutions for tightly sealing bags for isolation and waste disposal. They should insist on double-lock security to eliminate the possibility of accidental releases, and ensure the seal will last long enough to keep the contents secure for as long as required.
<h2>A High Containment Closing System for Long Term Sealing</h2>
The Ezi-Dock ezi-strap™ liner tie system is a fast, effective way for sealing sleeves and liners either manually, or pneumatically. Double-lock security effectively prevents accidental release, and it has useful anti-tamper and labelling capability. This is ideal for linear filling with materials sealed in a series of bags, or one-shot bag-out waste.

The ezi-strap™ system is user-friendly. It is strong and durable, and specially designed for ‘real world’ production environments. This product is hence ideal for relatively sensitive applications where spillage may result in troublesome contamination.

High containment closing system

In the medicine industry, it is important to ensure there are no defects in tablets or capsules. However, it’s a challenging task when combining high-speed production where thousands of tablets are produced every hour with high safety standards for highly toxic medicine. Sometimes highly toxic products, which operators cannot touch, are required to be delivered free from defects. Moreover, when the industry is producing various medicines including tablets, capsules, and soft gels, there is a need for a machine that can inspect and sort each category of product with great accuracy.
<h2>Inspecting and sorting in high-speed medicine production</h2>
The Sensum Spine Hypo is an inspection and sorting unit for highly toxic products with a fully automatic mode of operation in which defected products are detected and separated automatically. The Sensum Spine Hypo unit inspects the entire surface of a product (tablet, capsule, and softgels) at a speed of up to 360,000 products per hour. The products are transferred in the inspection system with a vacuum. A combination of six-colour cameras is used to thoroughly inspect the product. The active sorting system separates defective products with compressed air which fall under gravity to a compartment for defective products, while the perfect quality product moves forward for packing. Sensum Spine Hypo can be trained to identify the defects in new products by providing defect-free samples of the product. It will automatically recognize its colour, shape, thickness, etc. Once it is trained for the new product, which usually takes 10 minutes, the unit is ready for operation.

Sensum Spine Hypo performs 100 percent visual inspection, meaning, it scans all sides of the tablets, capsules or softgels to find any defects. The defects it can check for include the presence of a foreign product, colour deviation, shape, cracks, coating defects, thickness, chips, lamination defects, uneven surfaces, engraving defects, dirt, dots, damaged edges, and damaged prints.

The machine protects against contamination using inlet and outlet air filtering, the negative pressure in the process area, and using separation of the process with a barrier (gaskets, seals, silicone sealing). The inlet air filtering protects the clean room from air backflow, while outlet air filtering removes the dust from exhaust air. The separation barrier is another security against contamination supplemented by negative pressure in the process area. Moreover, Spine Hypo also enables use of contained feeding and discharging systems, such as safe connection to IBCs containers and continuous liners.

Sensum Spine Hypo has options for dry and wet cleaning in containment and has glove ports for safe access and interaction without breaking the containment. Dry cleaning with aspiration enables the removal of excessive surface powder accumulated during inspection and wet cleaning can be used to remove airborne powders from the process area of the unit.

Contained Visual Inspection System

During crime scene investigations in any movie, you've probably seen forensic scientists collecting evidence and biological samples in small containers. Here, these are the vials, used to store medicines, especially in liquid form, or laboratory samples. Often made of glass or plastic, vials can be labeled as single-dose vials or sterilized and reused more than once. They are also available with various closure systems depending on the material and storage requirements.

Vials

Pharmaceutical cartridges are glass containers of cylindrical shape, suitable for liquid or solid pharmaceutical dosage forms. Generally, these are designed for a specific apparatus such as pre-filled syringes and autoinjectors. Drugs that can be placed in cartridges using a pharmaceutical cartridge filling equipment include insulin, dental anesthesia, and other emergency drugs for allergies.

Pharmaceutical cartridges

Making.com is a new online platform that helps makers find production technology quicker by grouping it around the products they make.

Pharmaceutical packaging is a mix &amp; match of liquids/pastes/creams/solids &amp; vials/cartridges/syringes/tubes. And this is not even the entire range of options available today.

We asked how many machines pharma manufacturers need to fill the different formulas into the right container format.

Moritz Eggenberger answered that for us: just one system.

<a href="https://zellwag.com/" target="_blank" rel="noopener">Zellwag Pharmtech</a> developed a filling solution that handles multiple types of solutions and containers.

Besides filling, the innovative technology can be customized to meet varying handling requirements and capping techniques.

Nested containers with screw capping? Puck transport and stoppering? Buffer table combined with pilferproof capping? Check, check, and check.

Pharma packaging options are endless, but the filling &amp; capping system is one.

#Changemaker: One filling solution for all pharma containers

After being used to contain the blood of martyrs after death or to store the anointing oil of French monarchs, today ampoules are the first choice in packaging injectables. You create ampoules by melting the glass tube into the desired shape and seal them at the neck by melting the top of the glass tube. The only way for you to extract the contents from an ampoule is by breaking the glass at its breaking point, making it perfect for single dose applications only.

Ampoules

Automatic visual inspection of vials, ampoules, and syringes is a well-known and established industrial practice.

However, when it comes to small scale, it’s a different matter.



The Dutch company <a href="https://www.luoautomation.com/" target="_blank" rel="noopener">LUO</a> has used all its knowledge and passion for technology to develop automated visual inspection machines for small-scale pharmaceutical companies.

The company aims to help and support healthcare professionals to relieve the labor-intensive and time-consuming task of manual visual inspection of liquids for pharmaceutical applications. Their tabletop inspection machine can inspect up to 1.000 containers per hour.

#Changemaker: Automated visual inspection for pharmaceutical applications. Small scale companies, are you in?

Pharmaceutical

Parenteral preparations refer to drugs using non-oral means of administration. Injectables, such as needles and syringes, are used to deliver a drug into the systemic circulation directly in the veins, muscles, under the skin, or in the tissue.

These parenteral formulations are pharmaceutical dosage forms that have strict regulations on being sterile, pyrogen-free, and free from visible particulate matter including reconstituted sterile powders. Solutions, suspensions, emulsions, and gels with APIs intended for administration by injection are usually supplied in vials, ampoules, pre-filled syringes, or pens to facilitate ease of use.

Injectables

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