FILLING MACHINE FOR THE BIOMEDICAL, NUTRACEUTICAL, SPECIALTY CHEMICAL AND PHARMACEUTICAL INDUSTRIES
Although these products are separate and distinct industries by themselves, they do all share the same characteristics insofar as the type of filling machine that is suitable. These products almost always involve small, accurate fill volumes into small containers that are sometimes difficult to handle.
While this discussion does include filling machines used in the pharmaceutical industry there are oftentimes much more rigorous application requirements for pharmaceutical filling than in the nutraceutical, biomedical, and diagnostic specialty chemicals industries. Many pharmaceutical applications require complete, regulatory, validated control over all elements of the packaging process including not only the filling aspect but also container closing and handling. To accomplish this requires something much more than a simple, standalone filling machine; a multifunction machine described as a “monoblock” can perform all required functions. Otherwise, where the containers are more easily handled , a more simple standalone peristaltic filling machine can handle most applications in the biomedical, diagnostics, nutraceutical industries with some crossover into the pharmaceutical industry. In most cases, the liquid delivery systems used on these products are peristaltic pump or small pistons or micro positive displacement pumps. In all cases, they are digitally encoded servo drives to enhance accuracy and documentation of the system.
PERISTALTIC FILLING MACHINE FOR NUTRACEUTICAL, BIOMEDICAL AND DIAGNOSTIC REAGENT PRODUCTS
Biomedical, nutraceutical and diagnostic products are produced in small size glass and plastic vials. Normally these container sizes are not as small as some of the doses in pharmaceutical products. This makes these products suitable for conventional conveyor fed filling lines. Therefore, a standalone peristaltic machine is Ideal for these products because of the high accuracy required of these small fill sizes and also because many of these products have a high economic value per volume. Another very important feature of this delivery system is the fact that cross contamination of different products is virtually impossible if adherence to good manufacturing practices is followed.
Cross contamination is avoided in a peristaltic filling machine because the only thing that touches the liquid is the peristaltic tubing itself. This tubing is composed of surgical grade silicone or other inert specialty polymer materials. This tubing is inexpensive and can be easily cleaned, dedicated to a particular liquid, or simply thrown away after use. It can also be sterilized in an autoclave for reuse. The size of tubing chosen in this machine depends on the fill size and accuracy required. The smaller the diameter of tubing used, the higher the accuracy but the slower the fill rate. This explains why this machine is best utilized on small fills where high accuracy is needed. Large fill sizes greater than 1 liter are typically not filled on this type of machine because the fill cycle time can be lengthy. But for a typical fill size of 5 to 100 ml, again this is the ideal machine.
When the containers are so small as to not be handled manually or on a conveyor delivery system, a standalone peristaltic system is not practical. In this case, a peristaltic delivery system is installed on a mechanical platform better suited to physical container control. This system is called a monoblock system and typically features all liquid packaging operations in one platform.
MONOBLOCK FILLING MACHINE FOR PHARMACEUTICALS AND HIGH PURITY DIAGNOSTIC PRODUCTS
Automatic monoblock fill cap plug systems are typically small footprint platforms designed to handle small or inherently unstable containers that cannot be practically filled and closed on a intermittent straight line filling machine. These platforms are typically used for filling pharmaceutical and biomedical high purity products where the requirements for cleanliness are an extreme and/or where verifiable control and validation of all packaging parameters is required by the FDA or other regulatory agencies. These filling machine systems are usually found in controlled atmospheres i.e. “clean rooms” where the possibility of particle contamination is practically eliminated. Some monoblock systems incorporate their own laminar flow, hepa-filtered enclosures to isolate the containers in a controlled atmosphere thereby controlling contamination potential. Inline Filling Systems has built these capital machines with great success.
Small precise fills of controlled pharmaceuticals, injectables and diagnostic reagents followed by special closures such as stoppers, aluminum crimp seals, plugs and screw caps with precise application torque are accomplished on this platform. It should be noted that there are also some industrial chemical applications filling into larger bulk containers that have the same rigorous cleanliness requirements as pharmaceuticals. An example of this would be high purity solvents used in semiconductor manufacturing. Monoblock machines used in industrial applications like this are much larger in size than a typical pharmaceutical application.