Latest articles from the world of contract filling

Sterile filtration is the process by which liquid medicines are freed of microorganisms by passing them through a membrane filter with a pore size of

A pharmaceutical isolator is a closed barrier system that completely separates the aseptic filling area from personnel and the surrounding environment. A RABS, restricted access

Fill finish refers to the final steps of pharmaceutical manufacturing, in which a fully formulated product is filled under sterile conditions, closed, inspected and packaged.

Pharmaceutical contract manufacturing means producing medicinal products on behalf of other companies, from compounding the active solution to the packaged product. A contract filler, on

The IVDR, Regulation (EU) 2017/746 on in vitro diagnostic medical devices, has governed since 26 May 2022 how tests, reagents and control materials are placed

A buffer solution is an aqueous solution that keeps its pH value largely constant when acids or bases are added. In diagnostics and the laboratory,

Parenterals are medicinal products administered by bypassing the gastrointestinal tract, usually by injection or infusion. They include injection solutions in ampoules and vials, infusion solutions

Depyrogenation is the removal or destruction of pyrogens, above all bacterial endotoxins, on vials, ampoules and other packaging materials before sterile filling. Endotoxins are components

Water for injection, or WFI, is the purest water grade in the pharmacopoeia and the most important excipient for injections, infusions and eye drops. It

Container closure integrity, or CCI, refers to the tightness of a pharmaceutical container throughout its shelf life. A vial, an ampoule or a syringe must

A GMP audit is the examination of a manufacturer for compliance with Good Manufacturing Practice. Pharmaceutical companies carry it out at every contract filler before

Tech transfer in pharma means the planned transfer of a manufacturing process from one site to another, for example from the pharmaceutical company to a

Nearshoring means relocating production to a nearby country instead of to distant low-wage countries. In pharmaceutical production this model is gaining importance because supply chains

Drug shortages occur when demand for a medicine exceeds the available supply. One of the most frequent causes is not the active ingredient but the

A GMP certificate confirms that an authority has inspected a manufacturing site and established compliance with Good Manufacturing Practice. For pharmaceutical companies it is the

Process validation is the documented evidence that a manufacturing process reproducibly delivers a product of the required quality. In sterile filling it is one of

A media fill is the simulation of an aseptic filling process with nutrient medium instead of product. The filled units are incubated, and every turbid

Annex 1 is the annex to the EU GMP guide that regulates the manufacture of sterile medicinal products. The revised version has applied since 25

CDMO and CMO are two terms for service providers that manufacture medicines on behalf of others. A CMO, a contract manufacturing organization, takes over production

The Qualified Person, known in Germany as the Sachkundige Person, is the person who checks and releases every batch of a medicinal product before it

For many international pharmaceutical companies, contract filling is a key component of modern production strategies. When sterile medicinal products, injectables, vials, ampoules, ophthalmic products or

Contract filling of diagnostic products places high demands on precision, process reliability and consistent quality. Diagnostic reagents, control solutions, test liquids and laboratory consumables must

RTF processing is becoming increasingly important in pharmaceutical manufacturing. Ready-to-fill systems, RTF for short, enable the efficient filling of pre-sterilised primary packaging such as vials,

Ampoule filling for sterile injectables is one of the most demanding processes in pharmaceutical manufacturing. Ampoules are frequently used for sensitive injection solutions, where sterility,

The contract filling of eye drops is one of the particularly sensitive areas of pharmaceutical manufacturing. Ophthalmic products are applied directly to the eye and

Contract filling according to EU GMP is a central factor for pharmaceutical companies when medicinal products, sterile solutions, injectables, ophthalmic products or diagnostic applications are

Vial filling is one of the central processes in sterile pharmaceutical manufacturing. Vials are used wherever sensitive liquids, injection solutions, diagnostic reagents or other sterile

Sterile filling is one of the most demanding processes in pharmaceutical manufacturing. As soon as medicinal products, injectables, eye drops or other sterile solutions are

Key Takeaways Pharmaceutical outsourcing frees up capacity and significantly reduces capital expenditure Contract filling is particularly beneficial in the event of capacity bottlenecks, new product

Contract filling plays a central role in the pharmaceutical industry today. Manufacturers are under considerable pressure to comply with regulatory requirements, produce flexibly and reliably

Contract filling for medical devices is a highly regulated process in which errors are unacceptable. Companies that manufacture or distribute medical devices face the challenge

The industrial production of injection solutions is under considerable pressure. Increasing quantities, short time-to-market and uncompromising quality requirements often cannot be met economically in-house. This

Contract filling for ophthalmic products is one of the most demanding areas of pharmaceutical production. Eye drops, sterile solutions for ophthalmic applications and nasal sprays

Contract filling of medicines has been gaining importance for years because manufacturers are increasingly looking for flexible production partners who reliably combine precision, quality and

Contract filling of ampoules plays a crucial role in the pharmaceutical industry when it comes to the safe and economical filling of injection solutions, diagnostics

Ready-to-fill vials (RTF vials) are becoming increasingly important in the pharmaceutical industry. These pre-sterilized containers enable safe, clean, and efficient filling—especially for companies that rely

Sterile filling in accordance with GMP represents the key step on the path to marketable injectable drugs. While the formulation determines the efficacy, aseptic filling