Consulting assignments

We'll help you apply the right methods

Hygiene Diagnostics offers consulting services, training, and support to help youapply objective measurement methods for cleaning and hygiene in your business. 

As a customer, you have access to our product specialists and partners with expert knowledge. We’ll help you get started with the methods and ensure they work as intended. If any issues arise, we’ll work to resolve them quickly. 

We categorize our consulting services into Validation, Sanitation Inspection, Legionella Risk Assessment in Water Systems,and Project Assignments.

Validation

We can handle virtually any type of validation project in the pharmaceutical, medical device, and food industries. Our consultants possessadvanced skills that meet the requirements of GAMP 5, 21 CFR Part 11, Annex 11, and current GMPs for finished pharmaceuticals (21 CFR 211) and GMP regulations for medical devices (21 CFR 820).

We offer extensive expertise in cleaning validation as applied in food manufacturing, healthcare, and cleanroom environments, as well as for medical devices (ISO , FDA).

We can assist you in complex validation areas with our unique expertise in computerized analysis systems and standards. 

Health Inspection

We can perform certified quality monitoring in accordance with various standards, such as the Nordic cleaning standard INSTA 800, DS2451-10, or SS 8760014. Inspections are primarily conducted through visual assessment and, if necessary, supplemented with objective measurements.

Measurements may involve microbiological analyses (disinfection checks) or ATP hygiene cleaning checks). The results are compared against quality standards that must be established in advance. Once the checks have been completed, you will receive a report containing the following information:

  • Description of the item and quality profile
  • Who participates in the evaluation
  • Date and time of follow-up and last cleaning
  • Results of the visual inspection
  • Measurement method (if applicable) and results
  • Evaluation of results in relation to quality requirements and limit values
  • Comments and Suggested Actions

Legionella Risk Assessment

We offer professional Legionella risk assessments of drinking water systems in buildings and facilities. Through a structured review of the system’s design, temperature conditions, and operation, we identify risks associated with the growth and spread of Legionella.
 
The analysis is based on established methodology (FMEA) and includes:
  • Review of drawings and system design
  • Temperature measurements at critical points
  • Assessment of stagnation, VVC function, and usage patterns
  • Clear risk matrix and proposed priority actions
  • If necessary, we can perform rapid Legionella tests in consultation with the customer.
    A rapid Legionella test costs approximately 1,500 SEK.
You’ll receive a detailed and easy-to-understand report that can be used for internal monitoring, regulatory compliance, or as a basis for decision-making regarding corrective actions. This results inimproved operational reliability, reduced risk of Legionella, and better control over your drinking water system.
 

Project Assignment

Our project assignments can involve many different types of measurement methods and hygiene objectives. For example, this may involve helping clients evaluate their products or processes. Sometimes a pilot project is needed to verify that our analytical methods work as intended at our clients’ sites.

Perhaps you’re not sure what should be included in the project or need some advice? You’re always welcome to contact us to discuss your project needs

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