HERMES PHARMA specializes in the production of user-friendly oral dosage forms. As such, we have a long track record in handling moisture-sensitive products – and our facilities and manufacturing lines are designed for that.
We manufacture according to
- GMP (Good Manufacturing Practices) for medicinal products
- International standards for food safety such as HACCP (Hazard Analysis Critical Control Point) and US-CFR (Code of Federal Regulations)
- ISO 13485 for medical devices.
Our standards are regularly verified through audits and inspections conducted by customers and international authorities.
Crucial to the production of our effervescent tablets and effervescent instant drinks, as well as some chewable tablets, are intermediate granulates that resist humidity and protect sensitive APIs against acids and bases. We have developed patented technologies – TOPO and Continuous Flow (CF) – to optimize our granulates to work well with specific APIs. This makes our products more stable and less sensitive to moisture, especially when compared to conventionally manufactured effervescent products.
It's this combination of technology and expertise that allows us to develop superior products for our customers, giving them a competitive advantage in the markets they operate. If you'd like to partner with our team on your next project, get in touch now.
Our specialist manufacturing facilities
Our two manufacturing plants are highly automated ensuring fast throughput and inline packaging, minimizing the exposure of products to environmental conditions during the production process.
Our manufacturing plants specialize in:
- Weighing and blending
- Granulation technologies
- Coating technologies
- Filling, tablet compression and packaging
- Quality assurance and control
Weighing & blending
Weighing is the first step in pharmaceutical manufacturing – and it's critical for success.
We are experts in handling the many challenges involved:
Weighing accuracy – ensuring the correct amount of each ingredient is used in the mixture
Avoiding contamination – ensuring no dust or foreign particles can enter the mixture
Lot control – ensuring the traceability of each ingredient via electronic protocols
Handling large amounts of material – including movement both into and out of the facility. We have huge silos for raw materials that are joined to the production facility via an automatic weighing center that can handle around 6,000 tons of material per year
During the blending process, homogeneity is critical for achieving content uniformity. Every dose (whether that's an effervescent or chewable tablet, a sachet or stick pack) must contain the same amount of API, with as little variation within the batch as possible. Our special blending techniques achieve content uniformity when using even the smallest amounts of APIs in batch sizes of up to 1,500 kg. Content uniformity is essential in the manufacture of safe and effective pharmaceutical products.
Our effervescent formulations start out in a granular form. Granulation helps to provide the vital homogeneity of API distribution required in high-quality pharmaceutical products. The process turns powders into free-flowing, dust-free granulates designed to make further processing such as compression or filling in sachets easier.
A wide range of parameters must be determined and controlled throughout the granulation process. These include blend homogeneity, particle size, moisture, bulk density, porosity, hardness and compressibility. Expertise in assessing and optimizing all these characteristics is essential for ensuring a high-quality, commercially producible product.
We employ a range of granulation technologies including:
TOPO granulation technology
Continuous flow (CF) technology
Key benefits of TOPO and CF granulation technologies:
Sensitive APIs are protected against acids or bases
Our effervescent tablets and instant drinks are less sensitive to humidity and high temperature (climate zones III and IV)
We use granulates to form the basis for extremely stable products
No solvent residues are present in our final products
Taking user-friendly dosage forms should be a pleasant experience – both taste and mouthfeel are important factors in this. As user-friendly dosage forms tend to spend more time in the mouth, they are tasted more thoroughly than conventional tablets and capsules. This is why it is particularly relevant that the final product is palatable.
Beyond the use of flavorings, hot melt coating (HMC) is a specialist coating technology that we use to mask the unpleasant taste inherent with many APIs when e. g. manufacturing orally disintegrating granules (ODGs). HMC is faster than conventional coating technologies and eliminates the need for potentially toxic, flammable and expensive solvents. HMC also enables modification of the release profile to produce extended and immediate-release formulations.
Filling, tableting & packaging
At HERMES PHARMA, we use high-quality tableting equipment to press our lozenges, effervescent tablets and chewable tablets. In addition, we use an external lubrication method during compression to minimize the amount of lubricant within tablets. All products are immediately packed inline into primary packaging to minimize the risk of degradation through moisture or damage through mechanical handling.
We use the latest high-throughput equipment to package large batches of ODGs and instant drinks as stick-packs or sachets. When filling sachets with large amounts of API(s) (such as for our macrogol instant drinks), we have filling lines with two-component dosing systems that enable us to directly fill sachets with API(s), excipients and other ingredients. This avoids the need for preceding blending steps, which are usually necessary to mix the API(s) with other ingredients, maximizing batch sizes and reducing costs. For ODGs containing ingredients that are sensitive to oxygen, we use inert gases during the filling process. This minimizes the risk of any oxygen-related instabilities from occurring that could affect the quality of the final product.
For information on our wide choice of primary and secondary packaging options, including custom packaging options, please visit our user-friendly packaging pages.