Formulation and filling are key parts of any pharmaceutical production process, and they require the greatest level of quality and reliability. We offer a variety of filling technologies and services that help end-users run their businesses more reliably and flexibly while guaranteeing product quality is included in the manufacturing process.
Our automated system makes use of Alfa Chemistry sterile grade filters to reduce manual intervention and boost sterility assurance. With the filling technology series, end-users can develop more flexible multi-product manufacturing facilities by creating a comprehensive one-time flow path.
Please keep reading to understand more about the uses of our filling technique.
Disposable filling needles are a cost-effective and unique direct substitute for the stainless steel filling needles currently used for liquid aseptic filling, giving a cost-effective and unique direct alternative.
Featured product: Single-Use Filling Needles
This versatile needle fits easily into new or existing disposable filling lines with autoclaved or gamma-irradiated fluid paths. The filling machine's operation is simplified by the entire disposable assembly, which includes the needle, decreasing assembly time, and the risk of needle installation.
A polyether ether ketone (PEEK) shaft and polypropylene hub reinforced with non-fluid contact stainless steel make up the disposable plastic-filled needle. The needles come in six different sizes: 0.8, 1.6, and 3.2 mm with a female Luer connector, 3.2, 4.0, 5.0, and 6.0 mm with a direct tube connection, and 3.2, 4.0, 5.0, and 6.0 mm with a direct tube connection. It can be autoclaved or gamma-irradiated to be utilized in a disposable aseptic filling system.
Featured Product: Particle Verification Standard
The Alfa Chemistry particle verification standard service seeks to challenge and validate manual and automatic visual inspection methods by supporting the training and testing of human inspectors.
It performs fast and fully traceable testing of disposable systems at the point of use.
Featured product: LGR Test Instrument
LGR Test Instrument can test the integrity of filters in disposable systems and perform point-of-use leak tests on disposable systems with a nominal volume of up to 200 L. The technology has a tiny footprint, is simple to operate, and meets current regulatory requirements. The instrument enables the end-user to utilize a single device to evaluate an endless number of disposable systems and filters without jeopardizing the system's sterility.
Alfa Chemistry provides process solutions, technical support, and filling technology verification for the biotechnology industry.
Featured product: Helium integrity testing technology for 2D disposable systems
The helium integrity test system is a sophisticated integrity test that is used to improve patient safety during important processing steps of APIs or medicines. This test is capable of detecting flaws as small as 2 millimeters.
The highest level of control is provided by the helium integrity test, which ensures that the disposable system is 100% complete at the plant. The size of observable faults is proportional to the number of microorganisms that enter the system. It may be necessary to test container systems, mixer bio container systems, and disposable filling equipment.
Ultra-Clean Sterilizable Packaging
For autoclave, API, formulation, and filling applications, we offer ultra-clean and sterilizable packaging solutions.
Featured product: Medical Grade LDPE Bags
The bag is a medical-grade low-density polyethylene (LDPE) bag that is ideal for bottle stoppers, bottle caps, vials and containers, API, medical powder, buffers, media, filters, medical equipment, clean room clothes packaging, gamma radiation, and syringe components, among other things.
- Use certified virgin resin to extrude LDPE film internally without any additives
- Blown film extrusion, processing, and packaging of LDPE film in a certified cleanroom
- Flexible customization of size, thickness, and shape (bags, tubes, sheets, films, etc.)
- A dye penetration test (methylene blue) to show package integrity
- Low visible and sub-visible pollutant levels
- Low bioburden and endotoxin levels
- Low levels of extractables and extractables
- Cleanliness certification
- Improve process efficiency
- Gamma sterilizable up to 50 kGy
- Pre-sterilized bags are available on request (25 kGy gamma radiation, certified)