Guide Parenteral Products. The Preparation and Quality Control of Products for Injection

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For the aseptic manufacturing team, the challenge and thus the complexity is additive; a specific aseptic process would need to be designed and likely requires specific media fill qualification to ensure process robustness. A focus on the patient who will undoubtedly benefit through administration of a controlled, targeted-release product with reduced systemic exposure must be maintained.

This remains a strong driver for processes to adapt to emerging technologies and critical clinical applications. An increased requirement to handle potent active substances has been an ongoing trend, and suitable containment requirements for these compounds, particularly in multi-product facilities, has been a focus for pharma companies and CDMOs alike. This focus has been matched by the growth of single-use technologies that seek to minimize risk of product cross contamination in multi-use facilities. Single-use technologies also allow a modular approach in which complex fluid pathways can be designed as closed systems with sterile connectors.

The ability to design a bespoke irradiated fluid pathway that can be assembled in a cleanroom greatly assists the transition of complex processes from laboratory to cleanroom.

Parenteral Products – IV: Lyophillization & Preparation of Sterile

Increased automation removes operators from the aseptic core and barrier systems, which effectively remove the operator from the aseptic process and is highly advantageous in reducing risk in the cGMP manufacture of complex formulations. Differentiated filling technologies within Restricted Access Barrier Systems RABS or isolators may be necessary to support a broad range of formulation possibilities. Peristaltic pump processes are well suited to biologics, such as proteins and antibodies, in which sensitivity to shear is a concern.

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Peristaltic processes easily align with single-use technologies and rapid turnaround, reducing the requirement for product-specific cleaning and in turn allowing greater utilization of cleanroom facilities. This system is ideal for a dedicated process but less flexible in multi-product facilities and typically requires product-specific cleaning to minimize product carry over concerns. As a result, the requirement to evaluate alternative presentations, such as suspensions, emulsions, solvent based, or incorporating novel excipients, is also on the rise.

Whilst these remain an initial hurdle to overcome, appropriate solutions must also represent viable options for ultimate scale-up and cGMP manufacture. The complex formulation challenge can often represent the ability to define a robust process that facilitates drug product manufacture to target specification, whilst maintaining a practical aseptic process ensuring sterility assurance. They must align with regulatory expectations and be manufactured under strict aseptic control.

A decision tree for non-aqueous and suspensions is presented in Figure 1. Often, by necessity, the controls ensuring sterility of complex parenteral formulations lie close to the base of the decision tree. Design of the aseptic process and most critically, aseptic qualification of the manufacturing team, are of equal importance to the skill of the formulation scientist developing the robust complex formulation.

Success is delivered through knowledge transfer and a shared understanding of the broad complexity of the entire process. Teamwork is the foundation for success in delivering complex parenteral products to patients. An armory of techniques supporting pre-formulation and formulation development should be utilized at the appropriate phase of product development.

Bench-suitable screening tools used at the early, quick assessment stage should be replaced with scalable technologies as lead candidates emerge. A solid appreciation of aseptic controls is required for patient safety and can help guide the transition from candidate selection to process development. Cheminformatics pre-formulation , design of experiments formulation development , and critical process parameter assessment scale-up all assist in narrowing the selection process to identify scalable, robust development candidates. As an example, a poorly soluble drug substance may be developed as a liposomal product that may be assessed for suitability using high shear, high pressure, or ever-maturing microfluidics processes.

The connection between formulation scientist and the aseptic manufacturing team is equally important. Visual method 2. Microscopic count method 3.

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Light obstruction method 4. Coulter counter method 10 Visual method: Visual method 11 The containers are examined against strong illuminated screen. Black background is used for the detection of light colored particles and white background for dark colored particles. The solution is allowed to pass under this bright light. A shadow is formed if a particle is present. The particles are counted by the no. As particle passes through the orifice it displaces its own volume of electrolyte.

Particle detected by the increase in electrical resistance. Voltage pulses are proportional to the particle size. Particles below 0. Endotoxin - complex of pyrogenic lipopolysaccharide , a protein and inert lipid; lipid part of the lipopolysaccharide is the main pyrogenic agent; polysaccharide part increases solubility 17 Sources of pyrogen contamination: 18 Sources of pyrogen contamination solvent - possibly the most important source the medicament the apparatus the method of storage between preparation and sterilization Animals and equipment: Animals and equipment 19 selection of animals healthy, adult, not less than 1.

Of Rabbits Individual Temp. This technique requires positive and negative controls. Positive control — A known concentration of endotoxin added to the lysate solution Negative control — Water, free from endotoxins, added to the lysate solution. Opacity is directly proportional to the endotoxin concentration. This technique is used for water systems and simple pharmaceutical produts. The quantity of the p-nitroanilide produced is directly proportional to the endotoxin concentration.

Based on results obtained from testing the sample a decision is made as to the sterility of the batch. Sterility testing is made after the product exposition to the one of the possible sterilization procedures 35 Principle: Principle Sterility test is based on the principle that when microorganisms are supplied with nutrient medium and water, and incubated at favorable temperatures, they multiply.

The presence of micro organisms can be identified by turbidity in the clear medium. Types of media- 1. Fluid thioglycollate medium for anaerobic bacteria. Soyabean-casein digest medium for aerobic bacteria and fungi. If growth absent. Then sample passes the test. If microbial growth is present in the retest also, identify the organisms. If same organisms are found as in the first test, then the sample fails the test.

If different organisms are found, retest is performed using twice the number of samples. Passes if microbial growth is not found. Page no.


Akers and Daniel S. Larrimore, Parenteral Quality Control. Follow us on:. Go to Application. US Go Premium.

Different Types Of Parenteral Preparations

PowerPoint Templates. Upload from Desktop Single File Upload. Post to :. URL :. Related Presentations :. Add to Channel. The presentation is successfully added In Your Favorites. Views: Like it 0. Dislike it 0. Added: October 17, Posting comment Premium member. Presentation Transcript. Leakage Test: Leakage Test Ampoules are subjected to this test. Spark Test: Spark Test The machine uses high precision electrodes to inspect the full circumference of the containers, including the closure zone.