HP-APIs - Highly-Active Substances

HP-APIs

Highly-active substances, which are also called HP-APIs (High-Potency Active Pharmaceutical Ingredients)

The handling of HP-APIs is precisely regulated in Switzerland by Guideline 6508 of the Swiss Federal Commission of coordination for occupational safety and further regulations. Not only the manufacturing of highly-active substances, but also quality control must be carried out taking into consideration the special potential for danger posed by these particularly effective compounds. This places high demands on the infrastructure of the laboratory and the training of the staff.

Are you looking for a test laboratory that can analyse your highly active active ingredients? As a GMP accredited and FDA registered contract laboratory in Switzerland, we have the appropriate infrastructure and the suitable technical expertise for your analyses. Whether for physical, chemical or microbiological analysis methods - we will analyse your product. Do you have any questions about what you need to consider in your quality control?

 

We will be happy to advise you.

Read on here for more information or contact us.


What do we understand by an HP-API?

According to references (Bormett, 2008), highly-active substances are defined as follows:

  • a pharmacologically active substance or intermediate stage that displays biological activity in humans at a concentration of 150 μg/kg or less of body weight;
  • a pharmaceutical active ingredient with a maximum occupational exposure concentration of 10 μg/m3;
  • a pharmacologically active substance or intermediate stage with a high level of selectivity (e.g. binding to receptors or inhibition of enzymes) or a substance that can cause cancer or mutations;
  • a new compound, whose effect and toxicity is not yet known.

How do you protect yourself?

Hazard assessments are essential in workplaces where HP-APIs are handled. This assessment includes recording the type of HP-API used, as well as the type and duration of the activities performed by the employee. Furthermore, in the guidelines from SUVA, the Swiss accident insurance institute (2004), protection measures for handling during manufacturing, in the clinic and in the laboratory are described in detail.

Personal protective measures

  • Suitable work clothes
  • Protective gloves
  • Respirator masks
  • Protective glasses

Technical protective measures

  • Suitable spaces and facilities.
  • Manufacturing and sample preparation in a suitable safety cabinet or isolator.
  • Using technical aids such as pressure relief or transfer systems.

 

The use of systems for preparation which prevent the release of HP-APIs, particularly when there are no safety cabinets or isolators available.

  • The manufacturing and preparation of HP-APIs should be performed in a separated working area.
  • The working area must have sufficient and suitable ventilation.
  • The room ventilation technology must not compromise the functioning of the safety cabinet.
  • Working areas in which HP-APIs are manufactured and analysed must be labelled.
  • Work areas and surfaces should be smooth and easy to clean.

Organisational protective measures

HPAPI-analysis: Working in the biological safety cabinet
HPAPI-analysis: Working in the biological safety cabinet

A concept for prevention of a hazard in the event of:

  • Manufacturing and preparation
  • Transportation
  • Logistics in the company
  • Storage
  • For the disposal of these substances

For every one of the steps, guidelines and operating instructions (Standard Operating Procedures; SOPs) must be present, observed and checked. This particularly includes regulations for sample preparation, the choice of suitable analysis techniques and the correct usage and requalifying of the safety cabinets.

When handling HP-APIs in the safety cabinet, care should be taken that there is no prevalent high pressure or low pressure in the containers. Slow pressure equalisation must be taken into account particularly when removing objects from the injection containers. To protect employees, they should be trained in advance about the hazards and measures to be taken when working with HP-APIs. Responsibility for compliance with the guidelines and any applicable training measures lies with the person responsible for occupational safety.

Disposal of sample residues

Disposal of HP-API contaminated materials must be arranged with the Cantonal or communal authorities responsible.

Measures taken for waste disposal:

  • Waste containers must be liquid-tight.
  • Non-penetrable waste containers for pointed and sharp objects.
  • Special labelling for waste containers containing HP-APIs.
  • Contamination protection for the external surfaces of waste containers.
  • Protective clothing.
  • Safety cabinets suitable for low-contamination changing of filters.

Accidents can happen

Accidents can never be completely excluded, even after thorough planning. Provision should be made for the event. Define measures to be taken for cleaning and for unintended release. For example, commercial spill kits can be used to safeguard the contaminated zones and to safely absorb and dispose of the released substances.

Do you require additional information?

Please read the unabridged version in our technical article (see the right-hand column) or ask for advice from our customer services.


Our services in detail:

HP-APIs: HPLC analysis:
HP-APIs: HPLC analysis:

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Michael Trösch Graduate Chemist HTL

Tel. +41 58 434 42 00 Fax +41 58 434 42 01 service@ufag-laboratorien.ch

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