RSSL Food & Pharmaceutical Case Studies

Latest Case Study

commercialiation of a recipe for a chilled dessert

Method development and validation for multiple products

A supplements manufacturer asked RSSL to develop and validate two analytical methods suitable for the quantification of three vitamins across its extensive portfolio - all within a limited timeframe.

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Pharmaceutical and Biopharmaceutical

Foreign body contamination in intravenous drug products

Foreign, undissolved material are commonly reported in parenteral solutions. RSSL was asked to inspect a series of vials containing pharmaceutical drugs with suspected contamination, identified during the client’s QA screening processes

Pharmaceutical and Biopharmaceutical

Foreign material between the plunger and barrel in pre-filled syringes

RSSL was asked to investigate a batch of suspected ‘leaky’ pre-filled syringes detected during validation checks in the client’s filling process.

Pharmaceutical and Biopharmaceutical

GMP Culture From The Heart

Having made major investments in state of the art facilities and manufacturing equipment, the senior management team at Mentholatum believed it was also essential to invest in staff training.

Food and Consumer Goods

Evaluation of a Novel Ingredient for Regulatory Approval

An ingredient supplier was looking to apply for novel foods approval with a new ingredient they had developed.

Food and Consumer Goods

Nut Protein Contamination

A consumer complained that they had experienced a suspected nut allergic reaction to a ready meal.

Food and Consumer Goods

Particle Behaviour

A change of supplier can lead to physical changes in the behaviour of a chemically identical material, resulting in significant changes in the manufacturing process and final product.

Food and Consumer Goods

Tracking Down A Garlicky Odour

A drinks manufacturer reported several consumer complaints about a garlicky odour when bottles of drinking water were opened.

Food and Consumer Goods

Commercialisation of a recipe for a chilled dessert

The Product and Ingredient Innovation Team were approached by a client to support them with the commercialisation of a chilled dessert they had developed in a domestic kitchen.

Pharmaceutical and Biopharmaceutical

Contaminant in Veterinary Antibiotic

A common issue in pharmaceutical analysis is the appearance of extraneous peaks in HPLC-UV chromatograms. In a recent case a customer detected an unknown peak in the chromatogram of a veterinary antibiotic API.

Pharmaceutical and Biopharmaceutical

Foreign Material Contamination in a Pharmaceutical Tablet

RSSL was asked to investigate a dark foreign body contamination of pharmaceutical tablets, which had been detected during routine quality checks in the client’s manufacturing process.

Pharmaceutical and Biopharmaceutical

Monitoring Host Cell DNA and Protein Levels

Host cell DNA and protein contamination within biopharmaceutical products are strictly limited under the European Medicines Agency (EMA) guidelines.

Pharmaceutical and Biopharmaceutical

Tablet Coating Thickness Affecting Dissolution Testing

During a research and development project supported by RSSL on a new tablet coating, a pharmaceutical manufacturer encountered unexpected problems with dissolution testing.

Pharmaceutical and Biopharmaceutical

Highlighting US and EU GMP Differences

A US based client with an exciting drug product in development wanted to bring it to Europe as soon as possible.

Pharmaceutical and Biopharmaceutical

Medical device component failure investigation by X-ray Microtomography

A client’s investigation into cannula leakage through the injection port in a production batch was supported by RSSL in order to determine the cause, as well as potentially preventing a recurrence of this issue.

Food and Consumer Goods

Metallic Contamination Identification Using A Portable XRF

After a spate of metallic contamination issues, we were approached by our customer who wanted to understand the elemental composition of the various components and equipment on their primary production lines.

Pharmaceutical and Biopharmaceutical

Metallic Contamination Identification Using A Portable XRF

Pharmaceutical and Biopharmaceutical

Nanoparticle content present in raw materials

RSSL were approached by a client who wanted to understand more about the nanoparticle content present in their raw materials in order to assess their response to a potential legal challenge.

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Latest Case Study

Method development and validation for multiple products

All Case Studies

Foreign body contamination in intravenous drug products

Foreign material between the plunger and barrel in pre-filled syringes

GMP Culture From The Heart

Evaluation of a Novel Ingredient for Regulatory Approval

Nut Protein Contamination

Particle Behaviour

Tracking Down A Garlicky Odour

Commercialisation of a recipe for a chilled dessert

Contaminant in Veterinary Antibiotic

Foreign Material Contamination in a Pharmaceutical Tablet

Monitoring Host Cell DNA and Protein Levels

Tablet Coating Thickness Affecting Dissolution Testing

Highlighting US and EU GMP Differences

Medical device component failure investigation by X-ray Microtomography

Metallic Contamination Identification Using A Portable XRF

Metallic Contamination Identification Using A Portable XRF

Nanoparticle content present in raw materials

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