Techceuticals

What are GMPs and SOPs? Good Manufacturing Practices are guidelines designed to assure consistency and reproducibility in manufacturing. GMP or cGMP; Current Good Manufacturing practices are federally regulated by the FDA. The FDA is the Food and Drug Administration. They have established a Code of Federal Regulations (CFR). It is required by the FDA that each employee is responsible to follow and practice GMP’s. The manufacturing company can be held accountable for the employee not following the requirements of the GMP. Therefore companies have established SOP’s; Stand Operating Procedures. Standard Operating Procedures are written instructions for the employee to follow and sign. The employee must understand that their signature assures that they have completed the SOP step by step and has not changed any step. If an employee changes a step, an explanation must be written as to why, and a deviation must be recorded by the company. General Employee Procedures The employee i...

Capping & Lamination —  Capping is often referred to as air entrapment. During compression, air is evacuated from between the granules to allow the granules to lock to one another. If the “air” does not escape during the compression process the top of the tablet (the tablet cap) wants to come off. The tooling (punches and dies) are designed to allow air to escape during compression along the upper punch tip and die wall. This is why capping occurs on the top “cap” of the tablet. Capping is not just air entrapment. During compression air evacuation pushes the very fine dry granules out with the air. It is these dry and light particles that do not want to lock together, resulting in tablet “caps” wanting to come off the tablet. Lamination is when the tablet splits apart anywhere except at the upper cap. Lamination is often blamed on over compressing. Too much compression force flattens out the granules and they no longer lock together. Lamination can also occur when groups of fi...

Tooling  — A set of punches and dies are often referred to as tooling. A station of tools consists of an upper punch, lower punch and die. The job of the upper punch is to control compression position within the die. Most modern tablet presses have adjust upper punch entrance which means that the machine can be adjusted to control how far the punch enters the die. Typically a good place to start is around 3mm upper punch penetration into the die. If the upper punch is set too high the product maybe pushed out of the die before the upper punch enters the die. Many machines allow punch entrance as deep as 6mm. The problem with being too deep in the die is that air may become entrapped contributing to a capping issue. Notice that the upper is smaller in diameter than the lower. The Lower Punch The job of the lower punch is more complex than that of the upper. The upper punch only controls penetration depth into the die. The lower punch first overfills the die with too much powd...

Tablet Testing  — We need to test tablets as they are being made to assure that we are in control. Tablet weight is critical as is thickness, hardness, friability, disintegration, dissolution and visual inspection. Thickness is an important physical attribute. On the press thickness variation may mean there is a variation in weight and hardness or both. On the packaging floor, Bottle filling; thickness is important to allow for accuracy of count. A tablet that is too thick may not fit into the counting device, a tablet that is too thin may break, double-up and may also cause count accuracy issues. Blister packaging machinery requires very tight tolerances in tablet thickness to achieve and maintain accurate filling, count and sealing of the blister. Thickness is one of the main control features of a tablet press, the other is weight control and speed. Tablet thickness is a critical attribute and should be controlled with accuracy. Tablet Hardness Tablet hardness is the second ...

Tablet Compression —  Variations in powders will result in variation in the tablet, too much variation is considered a defect. If powders do not flow with consistency than all tablets will not compress the same. If the ingredients in the formula do not function properly the formula must be changed. Tablet compression is the event of squeezing powders together and driving the air from between the particles, resulting in a compressed tablet. The Tablet Press There are 2 basic types of tablet presses. Single punch and Rotary tablet presses. A single punch tablet press has one station of tooling. It Typically operates at speeds from 1 -60 tablets per minute. A rotary tablet press has multiple stations of tooling positioned on a rotary table. This rotary table is referred to as a turret. As the turret rotates the tablet tooling is guided from one position to the next by cams. The objective of the operator is to keep this turret clean and properly lubricated. A press that has been...