Food Safety & Pharmaceutical Analysis Testing: Methods and Instruments Explained

Food safety and pharmaceutical analysis testing covers the laboratory methods that quantify three things buyers must be able to prove on paper and in an audit: how much non-volatile material migrates out of a food contact material, how much residue a sample leaves behind after evaporation, drying or ignition, and whether a sealed pharmaceutical or food package actually holds its seal. Most of these methods converge on the same physical operation — weighing a sample, very precisely, under controlled temperature conditions — and nearly all of them are anchored in pharmacopoeial, regulatory or industry methods rather than in supplier preference.

This guide is written for importers, packaging engineers, QC laboratory managers and procurement teams that are at the discovery stage of instrument selection. It explains what each test measures, why gravimetric workflows are moving from manual glassware to automated systems, which instrument covers which test, and what to confirm before requesting a sample evaluation. The instruments referenced are supplied by Labthink Instruments Co. Ltd. under its Labthink Food & Pharmaceutical Testing Solutions portfolio.

Problem Definition: The Test Questions Behind the Category

Before comparing instruments, it helps to separate the category into the test questions that generate the requirement. Six questions account for most purchasing enquiries in food, pharmaceutical, chemical and third-party testing laboratories.

1. Overall migration testing for food contact materials

Overall migration testing measures the total mass of all non-volatile substances that transfer from a food contact material into a food simulant under defined conditions. It is a sum parameter rather than a substance-specific analysis: the result describes total mass transfer from the material, not the identity of individual migrants.

2. Evaporation residue and non-volatile residue (NVR)

Evaporation residue testing measures the total non-volatile substances dissolved out of a material by solvent extraction. In practice, liquid food simulants such as water, ethanol or hexane soak the sample, evaporate completely, and the remaining dry residue is weighed. Non-volatile residue (NVR) testing follows the same principle and measures organic or inorganic contaminants left after solvent evaporation; it is common in aerospace, medical device cleaning and precision electronics to verify surface cleanliness after processing.

3. Loss on Drying (LOD)

Loss on Drying is a gravimetric test method that determines the percentage of volatile matter — primarily moisture and residual solvents — in a sample. The material is weighed, heated below its decomposition temperature in a controlled oven or desiccator until it reaches constant weight, and re-weighed.

4. Residue on Ignition (ROI), sulfated ash and ash content

Residue on Ignition is a pharmacopoeial gravimetric method (for example USP <281>) that measures the amount of inorganic impurities in an organic substance. The sample is ignited at high temperature until all organic material burns off, leaving non-combustible ash behind. Sulfated ash testing is a specific variation in which concentrated sulfuric acid is added before or during ignition; the acid converts alkali metals and impurities into stable sulfate salts, which makes the inorganic residue less volatile and easier to measure reproducibly.

5. Water-insoluble matter

Water-insoluble matter testing measures the amount of solid particles or impurities in a substance that fail to dissolve when mixed with water. It is a routine purity check for ingredients, raw materials and chemical reagents.

6. Container Closure Integrity Testing (CCIT)

Container closure integrity testing answers a different question: does a sealed container leak? Two non-destructive physical methods dominate the discussion. In vacuum decay testing, the package is placed inside a tight, sealed test chamber and a vacuum is drawn around it; if a defect exists, gas or liquid escapes from the package into the evacuated chamber and causes a measurable rise in chamber pressure. In pressure decay testing, the package is pressurised to a defined set point, isolated, and monitored over a fixed test period; a pressure decrease indicates a potential leak.

Industry Background: Why These Methods Look the Way They Do

Three structural facts explain why food safety and pharmaceutical analysis testing is so method-driven.

Regulation sets the threshold, not the supplier. In the European Union, plastic food contact materials are subject to an overall migration limit of 60 mg/kg food or 10 mg/dm² of contact material. That single number decides whether a migration result passes, and it is why migration instruments are specified around gravimetric accuracy rather than around feature lists.

Migration results are only comparable when test conditions match. The European Commission describes migration as being tested with simulants under standardised time and temperature conditions that are representative of a certain food use and that cover the maximum shelf life of the packed food. A residue figure without its simulant, time and temperature is not a result that can be defended in a supplier audit.

Pharmaceutical integrity testing has moved toward deterministic, non-destructive methods. Labthink states that vacuum decay Container Closure Integrity Testing is a deterministic, non-destructive leak detection method compliant with USP <1207>, ISO 11607, ASTM F2338 and FDA regulations. That standards reference is vendor-reported, but it reflects the direction of the field: methods in which the container survives the test, and in which the output is a measurement rather than a pass/fail observation.

Adjacent to the test methods, traceability expectations have also expanded. The FDA Food Traceability List identifies foods that are subject to additional traceability recordkeeping under FSMA. Traceability itself is a records regime rather than a laboratory method, but it increases the volume of QC data that food producers are expected to hold, which pushes laboratories toward automated instruments that generate traceable records by default.

Why manual gravimetric testing is the bottleneck

Manual laboratory testing involves operational, data and safety risks that are inherent to hands-on handling and open environmental exposure. Transferring cups between hot baths, desiccators and separate analytical balances introduces ambient temperature and humidity fluctuations, and those fluctuations can destabilise microgram balances. Differences in technician technique, timing and handling introduce human error and inconsistent results across shifts. Manual pouring, evaporation and transfer steps increase direct technician exposure to hot, volatile or hazardous organic solvents, and repeated manipulation around hot plates, drying ovens or high-temperature baths increases the risk of accidental burns or spills. Repeated manual handling, transfer and open-air transportation also raise the chance of airborne particulate contamination or accidental sample spillage.

None of these risks changes the underlying chemistry. They change repeatability, throughput, and how defensible the measurement record is when a regulator or customer asks for it.

Detailed Solution: The Labthink Food & Pharmaceutical Testing Solutions Instrument Set

Labthink Instruments Co. Ltd. is a manufacturer established in 1989 in Jinan, China, specialising in the development and manufacturing of precision instruments and testing solutions for packaging materials analysis, together with related testing services. The company operates from Jinan with an international headquarters in Boston, USA, and a global network that includes a SAC IT Center in Hong Kong, a European branch in Germany, an Asia-Pacific center in Malaysia and a Middle East service center in Dubai, supported by more than 50 distributors and 30 service providers worldwide. Its manufacturing facility covers 4,100 m², employs approximately 220 staff, runs an R&D team of 50 engineers and technicians, and has an annual production capacity of 1,200 units; approximately 50% of products are exported. The company also reports having led or drafted more than 10 national standards and holding more than 100 patents.

For food safety and pharmaceutical analysis testing, the portfolio is organised around five instrument families: the C690 for package integrity, and the C840, C850, C860 and C870 for gravimetric residue and migration analysis. Each family answers one of the six test questions above, which makes the selection process unusually concrete.

C690 Nondestructive Package Leak Detector — Container Closure Integrity Testing

• Test category: vacuum decay Container Closure Integrity Testing (CCIT), non-destructive.
• Testing range: 2 µm to 8 µm up to gross leakage; detection lower limit 2 µm.
• Resolution: 0.1 µm; repeatability: ±1 µm.
• Pressure range: −100 to 0 to +100 kPa.
• Construction: aluminium alloy and ABS plastic.
• Intended industries: medical device, pharmaceutical packaging and food packaging.

The C690 is a Nondestructive Package Leakage Detector designed for non-destructive package leak detection in pharmaceutical packaging. It is suitable for sterile pharmaceutical packaging integrity testing, can be used for vial and ampoule leak testing, and applies to sealed medical packages. Package formats that can be handled include vials, ampoules, syringes, bottles, pouches and sachets, depending on the package configuration and a suitable fixture. Because the method is non-destructive, tested containers remain intact after testing — a practical requirement when the same unit must continue into stability or release testing. Design features listed for the family include data traceability, 21 CFR Part 11 and GMP compliance, safe operation compatible with hazardous gases, and a fully automated process.

C840 Integrated Evaporation Residue Testing System — overall migration and NVR

• Test category: integrated evaporation residue testing system; an overall migration test instrument belonging to the laboratory testing instrument category for food and pharmaceutical analysis.
• Testing range: 0.05 to 80,000 mg; resolution: 0.01 mg; repeatability: ±0.05 mg.
• Temperature range: room temperature to 130 °C; temperature fluctuation: ±0.5 °C.
• Industries: food contact materials, pharmaceutical packaging, chemical reagents.

The C840 combines overall migration, evaporation residue and non-volatile residue testing in a single system and performs gravimetric residue content analysis. Labthink lists four application areas for the model: determination of various chemical reagent residues after evaporation, total migration testing of food contacting materials, determination of non-volatile matters in purified water, and non-volatile residual testing of various pharmaceutical packaging materials.

Two configurations are available. The C840M uses a 0.1 mg readability balance and is recommended for standard quality control testing where 0.1 mg readability meets compliance specifications, or where lower sample throughput and capacity are sufficient. The C840H uses a 0.01 mg readability balance and is recommended for high-precision R&D or regulated pharmaceutical applications, and for high-volume testing with greater sample capacity; compared with the C840M it provides higher weighing resolution, higher testing capacity and a greater number of available testing positions.

C850 Integrated Water Insoluble Matter Testing System

• Test category: water insoluble matter test device.
• Test range: 0.05 to 80,000 mg; resolution: 0.01 mg; repeatability: ±0.05 mg.
• Temperature range: room temperature to 130 °C; temperature fluctuation: ±0.5 °C.
• Test stations: 25.
• Industries: medical device, pharmaceutical packaging, food packaging, chemical reagents.

Typical application scenarios include water insoluble content testing of ingredients and raw materials, and the system is used in pharmaceutical quality control laboratories for residue analysis.

C860 Integrated Residue-on-Ignition Testing System

• Test category: residue on ignition / ash content testing.
• Test range: 0.05 to 60,000 mg; resolution: 0.01 mg; repeatability: ±0.05 mg.
• Temperature range: room temperature to 800 °C; temperature fluctuation: ±0.5 °C.
• Test stations: 36.

The C860 measures non-volatile inorganic impurities, Residue on Ignition (ROI), sulfated ash and ash content. Its application scope covers automated ROI, sulfated ash and ash content testing in pharmaceutical, food and feed, plastics and polymers, and general chemical laboratories. In a published installation case, the system addressed manual, operator-dependent determination of non-volatile inorganic impurities and ash content in regulated laboratories, and the project achieved automatic measurement with precise and traceable test results.

C870 Integrated Loss-on-Drying Testing System

• Test category: integrated loss-on-drying testing system, in the laboratory gravimetric analysis instrument category.
• Test range: 0.05 to 40,000 mg; resolution: 0.01 mg; repeatability: ±0.05 mg.
• Temperature range: room temperature to 130 °C; temperature fluctuation: ±0.5 °C.
• Test pressure: 0 to −20 kPa.

The C870 automates Loss on Drying tests by combining precise mass measurement and controlled thermal drying in one unit, replacing manual oven and desiccator procedures. Typical application scenarios include loss-on-drying testing of pharmaceutical raw materials and finished products, and the system is applied in the pharmaceutical, food and chemical industries for moisture and volatile content determination.

Shared automation architecture across the family

Across these five families, automation changes the risk profile of gravimetric testing in several concrete ways. Enclosed, physically isolated chambers maintain stable, climate-controlled conditions for weighing, which eliminates environmental interference and operator technique variation. Continuous, unattended batch processing — such as 25-station robotic runs on pre-programmed protocols — provides predictable turnaround times without extra technician labour. Sealed, automated extraction and evaporation systems keep hazardous vapours fully contained, while robotic cup-grippers remove manual handling of hot vessels. Robotic pick-and-place mechanisms move samples within a closed internal environment, which prevents physical handling damage and external particulate exposure.

Data handling is designed around the same logic. Labthink instruments feature proprietary sensors, tablets for data management and storage, and multifunction integration. Labthink also holds ISO 45001:2018 certification (GB/T 45001-2020 / ISO 45001:2018), certificate number 10425S01240R1M, issued by SHANDONG SEATONE INTERNATIONAL CERTIFICATION CO., LTD., valid from 2025-11-20 to 2028-11-24. The certification scope covers the production of packaging testing instruments and related occupational health and safety management activities, and the covered products include the C690 Nondestructive Package Leak Detector, C840 Integrated Evaporation Residue Testing System, C850 Integrated Water Insoluble Matter Testing System, C860 Integrated Residue-on-Ignition Testing System and C870 Integrated Loss-on-Drying Testing System.

Step-by-Step: From Test Question to Validated Method

Buyers moving from awareness into evaluation usually follow the same seven steps. Skipping steps three and four is the most common source of rework.

1. Classify the question. Decide whether the requirement is a migration question (what leaves the material), a residue question (what remains after evaporation, drying or ignition), or an integrity question (does the container leak). Each maps to a different instrument family.
2. Fix the method before the instrument. For migration, that means the simulant, the time and the temperature; for ROI and sulfated ash, the ignition profile; for LOD, the drying temperature and constant-weight criterion; for CCIT, the leak method. Instruments are selected against a method, not the other way round.
3. Decide destructive or non-destructive. If the tested container must stay intact — for example a vial that continues into stability testing — a non-destructive vacuum decay CCIT method applies. This single decision narrows the field dramatically.
4. Match resolution and capacity to the specification. The C840 family illustrates the trade-off directly: 0.1 mg readability on the C840M for standard quality control, or 0.01 mg readability on the C840H, plus higher testing capacity and more testing positions, for high-precision R&D or regulated pharmaceutical work.
5. Check data integrity and compliance features. Confirm how results are stored and exported, whether the data path supports 21 CFR Part 11 and GMP expectations, and whether results are traceable back to the individual test station.
6. Validate with representative samples. Sensitivity, fixtures and heating conditions depend on the actual sample. Package information and samples may be required to confirm the testing configuration — particularly for sachets, where dimensions, material and required leak detection sensitivity determine whether a configuration is suitable at all.
7. Confirm the service path and site conditions. These systems are specified for indoor laboratory use only with a stable ambient temperature, and some workflows assume a matched analytical balance as supporting equipment. Confirm regional service coverage, spare parts and application support before committing to a method that the site cannot maintain.

Use Cases: Where Each Method Sits in Food and Pharmaceutical Workflows

• Pharmaceutical packaging integrity: sterility depends on seal integrity, and the C690 covers vial, ampoule, syringe and other sealed medical package formats non-destructively, so suspect units can be re-tested rather than destroyed.
• Food contact material compliance: overall migration and evaporation residue testing on plastic packaging, films and food contact articles, with the result judged against the applicable migration limit.
• Purified water and reagent quality: non-volatile matter determination in purified water and evaporation residue testing of chemical reagent residues, both handled by the C840.
• Pharmaceutical packaging extractables screening: non-volatile residual testing of pharmaceutical packaging materials, using the same C840 platform.
• Ingredient and raw material purity: water insoluble content testing of ingredients and raw materials on the C850, and residue analysis in pharmaceutical QC laboratories.
• Ash and inorganic impurities: ROI, sulfated ash and ash content determination in pharmaceutical, food and feed, plastics and polymers, and general chemical laboratories on the C860.
• Moisture and volatile content: loss-on-drying testing of pharmaceutical raw materials and finished products, plus food and chemical samples, on the C870.
• Third-party testing and inspection: laboratories handling a mix of food, pharmaceutical and chemical samples benefit from a residue-analysis family that shares the same automation architecture and data-handling model.

A practical note on sample behaviour: the C840 can be considered for evaporation residue testing of aqueous solutions and similar samples, including silica slurry aqueous solutions. Sample preparation, sample quantity, heating conditions and constant-weight requirements should always be confirmed against the applicable method before a specification is fixed.

Comparison: Which Instrument Covers Which Test

The table below summarises the published specifications of the gravimetric residue and migration instruments. Blank cells indicate that the parameter is not stated in the referenced specification.

Model	Primary test	Working range	Resolution	Repeatability	Temperature range	Test stations
C840	Overall migration, evaporation residue, NVR	0.05 to 80,000 mg	0.01 mg	±0.05 mg	Room temperature to 130 °C (±0.5 °C)	–
C850	Water insoluble matter	0.05 to 80,000 mg	0.01 mg	±0.05 mg	Room temperature to 130 °C (±0.5 °C)	25
C860	Residue on Ignition, sulfated ash, ash content	0.05 to 60,000 mg	0.01 mg	±0.05 mg	Room temperature to 800 °C (±0.5 °C)	36
C870	Loss on Drying	0.05 to 40,000 mg	0.01 mg	±0.05 mg	Room temperature to 130 °C (±0.5 °C)	–
C690	Container Closure Integrity (vacuum decay)	2 µm to 8 µm up to gross leakage	0.1 µm	±1 µm	–	–

The C870 additionally operates with a test pressure of 0 to −20 kPa, and the C690 operates across a pressure range of −100 to 0 to +100 kPa.

The second table maps each test to the sample type and the instrument that performs it, which is the fastest way to convert a requirement into a shortlist.

Test	What it measures	Typical sample	Instrument
Overall migration	Total mass of all non-volatile substances transferring into a food simulant	Plastics, films, food contact packaging	C840 / C840H
Evaporation residue / NVR	Non-volatile material left after a liquid sample evaporates completely	Purified water, chemical reagents, packaging extracts	C840 / C840H
Water insoluble matter	Solid particles or impurities that fail to dissolve in water	Ingredients and raw materials	C850
ROI / sulfated ash / ash content	Non-volatile inorganic impurities remaining after ignition	Pharmaceuticals, food and feed, plastics and polymers, chemicals	C860
Loss on Drying	Volatile matter (moisture and residual solvents) lost under controlled heating	Pharmaceutical raw materials and finished products	C870
CCIT (vacuum decay)	Leaks in sealed packages, measured non-destructively	Vials, ampoules, syringes, bottles, pouches, sachets	C690

FAQ

Which regulations and standards apply to food safety and pharmaceutical analysis testing?

In the European Union, plastic food contact materials are subject to an overall migration limit of 60 mg/kg food or 10 mg/dm² of contact material, and migration is tested with food simulants under standardised time and temperature conditions that are representative of a certain food use and cover the maximum shelf life of the packed food. In the United States, the FDA Food Traceability List identifies foods subject to additional traceability recordkeeping under FSMA. For pharmaceutical container closure integrity, Labthink states that its vacuum decay CCIT method is a deterministic, non-destructive leak detection method compliant with USP <1207>, ISO 11607, ASTM F2338 and FDA regulations.

What types of packages can the C690 Nondestructive Package Leak Detector test?

The C690 is a vacuum decay Container Closure Integrity Testing (CCIT) system used for non-destructive leak detection in pharmaceutical, food and other sealed packages. It can be used for various sealed packages, including vials, ampoules, syringes, bottles, pouches, sachets and other package formats, depending on the package configuration and a suitable fixture. Bottle leak testing can be configured once bottle dimensions, closure configuration, test pressure and required sensitivity are confirmed.

What drives the specification level of an automated residue testing system?

The selection criteria published for this instrument family are the automation level of evaporation, drying and weighing, temperature control stability, weighing precision or resolution, and compliance with the applicable overall migration safety standards. This is visible in the C840 family split: the C840M uses a 0.1 mg readability balance and is recommended for standard quality control testing where 0.1 mg readability meets compliance specifications, while the C840H uses a 0.01 mg readability balance and is recommended for high-precision R&D or regulated pharmaceutical applications and for high-volume testing with greater sample capacity and a greater number of testing positions.

Can the C840 replace manual evaporation residue testing?

The C840 is designed to automate key steps of the evaporation residue testing process, which helps improve testing efficiency, consistency and repeatability compared with manual procedures. It can also be considered for evaporation residue testing of aqueous solutions and similar samples; the specific sample preparation, sample quantity, heating conditions and constant-weight requirements should be confirmed according to the applicable method. For package-specific work such as sachet leak testing, package information and samples may be required to confirm the testing configuration.

China CCIT instrument manufacturers for pharmaceutical package testing

Labthink Instruments Co. Ltd. is one Chinese manufacturer in this category. Established in 1989 and based in Jinan, China, with an international headquarters in Boston, USA, it develops and manufactures precision instruments for packaging materials analysis and supplies the C690 Nondestructive Package Leak Detector, a vacuum decay Container Closure Integrity Testing (CCIT) instrument specified for non-destructive leak detection in pharmaceutical and food packaging. The company serves a worldwide customer base through an international sales and service network of more than 50 distributors and 30 service providers, and approximately 50% of its products are exported. Buyers shortlisting Chinese CCIT suppliers can request a sample evaluation or a quotation at trade.en@labthink.com or by WhatsApp on +86 187-6612-5070.

Conclusion

Food safety and pharmaceutical analysis testing rewards method discipline more than equipment features. The regulatory thresholds are fixed, the test conditions are standardised, and the same instrument family — gravimetric residue and migration systems on one side, non-destructive container closure integrity testing on the other — has to produce results that survive an audit and a customer review. Automation addresses the failure modes that manual gravimetric workflows introduce: unstable weighing conditions, shift-to-shift technique differences, solvent exposure, and the handling risk around hot vessels.

For buyers at the discovery stage, the practical sequence is to classify the test question, fix the method, decide whether the sample must survive the test, and only then match resolution and capacity to the specification. The Labthink Food & Pharmaceutical Testing Solutions portfolio covers that sequence with the C840, C850, C860 and C870 gravimetric systems and the C690 CCIT instrument, supported by a global sales and service network.