My first time with Sterile Pharmaceutical Products

In my third year of my Bachelor of Pharmacy, I did a course called Sterilization of Pharmaceuticals Products for a whole semester. It was an introduction to pharmaceutical products that were prepared in a special sterile and aseptic environment. We learned a lot about sterilization ranging from the understanding of how a sterile and aseptic environment is created such as how a room is designed to be as sterile as possible to the process of making sterile and aseptic pharmaceutical products. We had two rooms available, where within the big room was a smaller room that was closed off and had an airlock passage. The smaller room had positive pressure, meaning when entering there was air coming out from within the room decreasing the chance of the person bringing in any contaminants from outside. As one of our assignment, we had to design a sterile room — fun times! Within the sterile and aseptic smaller room to United States Pharmacopoeia 797 Guidelines standards (or as close as we possibly could), we were dressed in these full white suits and worked under laminar flow hood so that we could never contaminate the product. It was a very interesting semester indeed.

In this blog, I will describe how we made our pharmaceutical products label and the sample production record that described what we used along with our methods of doing the procedures.

Aseptic: Free from contamination caused by harmful bacteria, viruses, or other micro-organisms. Preventing infections and is free from pathogenic micro-organisms [1].

Sterile: Free from bacteria or other living micro-organisms; totally clean [2].

Sterilization: Any procedure that aims to remove, eliminate, or kill all life forms and other biological organisms [3]. We autoclave our equipment at 121 degrees Celsius for at least 30 minutes or 132 degrees Celsius for at least 4 minutes to reach the standards [4].

Sample Production Record

Our sample production record resembled a white A4 sheet attached on a clipboard that demonstrated the key points and what was needed to do. The methods are not meticulously described as it was expected that we knew what we were doing from our previous readings and the demonstrations from our lecturers and demonstrators.

1. A title of your establishment needs to be in place along with your Sample Production Record.

2. There needs to be the description of the product such as Calcium Gluconate Ampule followed by the strength. This can be described as weights in grams per 100 millilitres or volume in millilitres per 100 millilitres. There is a need for nominal volume which describes exactly how much you going to make and an actual volume is how much there will be produced during the process. Actual volume will always be more to compensate mistakes or spills but in the industry, it is perfectly calculated and there would never be that much difference between the volumes as mistakes are minimal and accuracy extremely high. A batch size needs to be shown so that we know how much is produced in what volume.

3. The reference number is really important in knowing when a pharmaceutical product was made and which batch it came from. This can always be useful when doing recalls of certain products. Depending on which country you are, recalls have different categories that describe the risks to the population, for example, the United States Food and Drug Administration makes international recalls [5]. My reference number system went like this — I made my pharmaceutical products on a Thursday, it was the second pharmaceutics practical and that was my second pharmaceutical product hence: Th-P2-002. With this, I knew exactly what day and around what time I made it. Although, there is always room for improvement in making better and more accurate reference number.

4. Describing the ingredients or chemical used is important along how much in grams there is per dosage, how much volume in millilitres per dosage and the total quantity used to make the batch. It all depends on your pharmaceutical product, the unit of measurement will change accordingly.

5. The equipment used needs to be in a list and grouped accordingly. Two columns, sterile or non-sterile, should describe if your equipment is sterile or if it is non-sterile. If it is not sterile and later cleaned, it needs to be described how and when.

6. The method of manufacture needs to describe succinctly and effectively on how to make the following pharmaceutical product. It is expected that the individual knows what he is doing hence the lack of long explanation on how to go on about it.

7. Finally, the person needs to sign and preferably a second person can also sign as the main supervisor. The date and time need to be noted. I remember doing a placement at an extremely sterile room at a tertiary hospital level in the making of chemotherapy drugs. Every measured volume or grams were supervised by someone and two signatures were needed to confirm the volume or weight so that there was the exact amount present. Remember that the intravenous bag containing the chemotherapy drugs will go straight into the cardiovascular system meaning it bypasses all the defences of the patient. A contaminated product could be extremely dangerous in a patient’s bloodstream.

The Pharmaceutical Sterilization Label

The label is very important in terms of what your product contains and it needs to successfully display the information across for anyone who will be using it or administrating it. Different organization will have different displays of their labels.

1. The Label needs to start with a caution or warning if it needs to have one. The usual “keep out of reach from children” or other warnings may be added but it will depend on what is being made and at what settings (hospital or other places). For example, if it is at a hospital setting and only nurses use it, there will be no point in putting “keep out of reach from children”.

2. Generally, the name of your product can be big and in bold. This can describe exactly what the product contains such as Procaine and Adrenaline Injections so that it is easy to read and decreases misreading or mistakes. Underneath the product name, the description of which British Pharmacopoeia (BP) and at what year can be mentioned. This helps us know the standards taken and how it was made as BP describes exactly every step.

3. Next comes the Active Pharmaceutical Ingredients (API) that are described as either in percentage or millimoles per litres (if necessary) or in parts per thousand/million (it all depends on the institution ways of things). After the API comes the other molecules or ingredients used with a description of their usage and what they do. They can also be described as a percentage or millimoles per litres (if necessary) or in parts per thousand/million depending on the establishment.

4. Lastly, there needs to be a date of when it was prepared with a description on how to stock and warnings of any disintegration factors that could degrade the product making it redundant, less effective or lethal. These factors are: sunlight, temperature, humidity or other compounds that could cause degradation such as acids or bases. The reference number needs to be present so that we can trace it back to its original batch if there is a need for any recall of the product. This also helps in keeping track of each pharmaceutical products. If necessary, in the end, there can be a mention of where it was made.

More examples from our Pharmaceutics practicals

Sample Production Record

Pharmaceutical Sterilization Label

From the Author

A short and sweet blog on how to make a simple label and sample production record. I am sure there are many ways these can be done as Standard Operating Procedures (SOPs) are generally used as the guidelines whenever making pharmaceutical products, especially under sterile and aseptic conditions. SOPs are step-by-step instructions that are made by an organization and helps the workers to carry out complex routines of operations [6]. This aims for efficiency, standardization and quality output. We had to make SOPs during my pharmacy studies and whenever there was a mistake while doing the procedures we had to write down why and how it happened. Making an SOP is very tedious and takes a lot of attention to details.

To our standards and how we did things, these labels and sample production record was satisfying and we did learn a lot about making pharmaceutical products. I hope you have too!

Published 28th February 2019. Last reviewed 30th December 2021.

Reference

1. Merriam-Webster. Aseptic. https://www.merriam-webster.com/dictionary/aseptic. Accessed February 11, 2019.

2. Journal of Wound, Ostomy and Continence Nursing. Clean vs. Sterile Dressing Techniques for Management of Chronic Wounds: A Fact Sheet. https://journals.lww.com/jwocnonline/fulltext/2012/03001/Clean_vs__Sterile_Dressing_Techniques_for.7.aspx. Accessed February 11, 2019.

3. Difference Guru. Difference between Aseptic and Sterile. https://difference.guru/difference-between-aseptic-and-sterile/. Accessed February 11, 2019.

4. Centres for Disease Control and Prevention. Guideline for Disinfection and Sterilization in Healthcare Facilities(2008), Steam Sterilization, Overview. https://www.cdc.gov/infectioncontrol/guidelines/disinfection/sterilization/steam.html. Accessed February 11, 2019.

5. United States Food and Drug Administration. Drug Recalls. https://www.fda.gov/Drugs/DrugSafety/DrugRecalls/default.htm. Accessed February 13, 2019.

6.Bhattacharya J. Guidance for Preparing Standard Operating Procedures (Sops). J Pharm. 2015;5(1):29-36. http://www.iosrphr.org/papers/v5i1/Version-2/E0512029036.pdf. Accessed February 13, 2019.