Unlike other industries, the aroma chemical industry requires additional care and quality systems to take care of the smell. We can actually envision this industry selling the scent instead of the products. To meet this requirement, the following quality systems and procedures ensure overall quality assurance from the receiving stage to the shipping stage.
IN]. Stage receipt:
All incoming raw materials and packaging materials must be stored in a spacious storage area with clear demarcations for approved materials and rejected materials.
Every batch of raw material and packaging material must be thoroughly checked against approved specifications, even minor deviations must be noted and investigated.
The packaging material must be inspected from the point of view of odor.
All approved lots should be labeled with green “APPROVED” labels and rejected lots with red “REJECTED” labels for better visual control.
B]. Manufacturing stage:
All processes should have well documented and authorized standard operating procedures.
The record sheet for each process must reveal the traceability of the materials used in the process.
There should be well validated and documented cleaning procedures with schedules to avoid cross contamination.
All containers used for the storage of materials in the Manufacturing area must have the appropriate labels to eliminate cross contamination and confusion.
vs]. Mix course:
This is a very crucial stage of quality control; the different fractions should be stored separately with appropriate labels indicating purity and odor status.
Make small 1kg mixes (called premixes) and test for odor and analytical parameters, if they are found to be ok then the final bulk mix will be made in the same proportion as the premix.
Storage tanks should be equipped with nitrogen purging and adequate aeration to remove odors.
D]. Laboratory controls:
Infrastructure: The quality control department must have the following infrastructure.
1]. Analytical Instrumentation Laboratory
2]. Wet analysis laboratory
3]. Olfactory analysis chambers
4]. control sample room
5]. Market sample preparation room
6]. documentation room
The laboratory must be well equipped with modern instruments to monitor different physical and chemical parameters to ensure that the product meets global standards. The instruments mentioned below are required.
1]Tintometer: To measure the color of liquid materials
2]Refractometer: To measure the refractive index, a very important parameter
3]Densitometer: To measure the density
4]Automatic titrator: to determine the acid number and the test
5]Karlfisher: To determine the moisture content
6]Polarimeter: To determine the optical rotation
7]GLC: To determine impurities and purity
8]GLC/GCMS with Head space: To determine volatile impurities as solvents at the PPM level
9]AAS: to determine metallic impurities such as iron, lead, mercury, etc.
10]Boiling and melting point apparatus: To determine the MP/BP
11]Chamber of stability: to derive compatibility of packaging material and storage conditions
my]. Odor analysis:
There must be an olfactory panel of at least 3 members to evaluate the smell of the different fractions in order to make a correct final mix. Panel members must undergo periodic tests to monitor their odor analysis capabilities. The olfactory analysis chamber should be clean and tidy and kept under positive pressure to prevent external odors from entering and members should be odor free in the sense that they should not use perfumes, aftershave lotions or scented hair oils etc. The olfactory analysis must be carried out from light odors to strong odors. The odor analysis should be recorded for the top note, the middle note, and the final note.
Panel members should refresh themselves by smelling the coffee beans whenever they feel exhausted. Used scent strips should be disposed of in the container containing the water to prevent the spread of odours.
F]. Documentation: There must be a good documentation system according to the following list.
Quality assurance:
1]. RM/PM Specifications
2]. Specifications of materials in process
3]. Finished Product Specifications
4]. test procedures
5]. customer specifications
6]. deviation reports
7]. Analytical Instrument Calibration Record
8]. Record of control samples
9]. test reports
10]. Material Physical Inspection Records
eleven]. Olfactory analysis record
12]. Supplier audit reports
G]. Production:
1]. manufacturing procedures
2]. Cleaning procedures for production equipment.
3]. Equipment Calibration Record
4]. Production batch record sheets
5]. Corrective actions record of deviations
6]. In-process sample analysis reports
7]. Mixing activity logs
G]. Packaging:
When it comes to packaging, only new, odor-free packaging materials should be used at all costs. Used drums should not be used.
The compatibility of the packaging material must be tested before finalizing the packaging material. Compatibility must be tested for the following parameters after storing the material for at least one month.
1]. smell and taste
2]. Purity
3]. Color
4]. Clarity
5]. pH
6]. Acidity index
7]. Heavy metal
8]. leaks
New packaging material suppliers should also be evaluated based on the above parameters.
H]. Storage:
This is the crucial and critical installation required to maintain quality through the useful life. The facility must be spacious enough (depending on the number of products and production capacities) to keep the different batches of QA-approved products separately while maintaining a minimum distance of 1 meter for easy access. Drums/bottles should be stored on wooden/plastic pallets. There must not be any water leakage from the roof. The temperature inside the warehouse should be kept between 25 and 30 degrees C, as aroma chemicals develop color and acidity when exposed to higher temperatures. Material older than six months must be retested for quality assurance.
YO]. Quality systems:
In addition to the above internal monitoring quality systems, the following external certificates in quality, safety, environmental and social affairs are essential to becoming a globally recognized aroma chemicals organization.
1]ISO-9000-[Quality management system]
2]ISO-14000[Environment management system],
3]OSHAS-18000-[Occupational safety and health administration system ]
4]ISO-22000 and HACCP-[Food safety management system]
5]GMP-[Good manufacturing practices as per FDA]
6]REACH registration – [For export to EUROPE]
7]SA-8000- [Social accountability system]