QUALITY CONTROL TESTING OF PACKAGING MATERIALS
4. PACKAGING DESIGN AND SPECIFICATIONS
Quality control of a packaging component starts at the design stage. All aspects of a pack development that may give rise to quality problems must be identified and minimized by good design.
(A) Component Shape and Dimension
Standardizing both component shape and size should be the policy. There are many components that can be standardized such as ampules, vials, cartons, labels and leaflets. Rubber plugs and plastic bottles can be standardized with respect to shape and size, varying only in the material of construction. There will be a variety of sizes of components depending on the dosage, but again the same shape could be used but with different dimensions.
(B)Packaging Validation Trials
When the components have been identified for a particular product, the validation of packaging operation is required. This is to ensure that a consistent pack quality is obtained at the required packaging rate.
(C) Material of Construction
The material of construction requires careful consideration, particularly when the product is in contact with the container. It is necessary to ensure that the product does not deteriorate or does not become contaminated as a result of being in contact with the container, or that the product does not affect the integrity of the pack.
(D) Component /Product Validation
Once a formulation has been agreed, the pharmaceutical company has to perform compatibility studies between the product and container to ensure the product degradation does not occur during the product market life. The container has to be capable of protecting the product from environment.
1. Sterile product validation:-
a) Product and pack compatibility- the components must be washed and sterilized through a validated procedure. The vials must be filled with the sterile product under sterile conditions and terminally sterilized if this is a part of the intended product operation. Components performance should be monitored during the compatibility trials to ensure that deterioration has not occurred.
b) Seal integrity- the seals of each vial should be examined before the experiment to ensure that there are no defectives, and then each vial should be inserted into a tray containing the challenge bacteria. The samples should be cycled through temperature and pressure changes expected on the market for several weeks. Careful cleaning of the vials and examination of contents for sterility will determine the seal quality.
2. Nonsterile product validation:-
a) Water vapour permeability- the water vapour permeability of the pack containing the product is required. This is necessary because although the bottles will comply with the water vapour permeability test described in USP, permeation through the bottle wall will depend on wheather the product has a high or low affinity for the water. The test split into two parts to enable the maximum amount of information to be obtained and hence possibly eliminating the necessity to perform further time consuming experiments.
· Bottle wall permeation
· Bottle and cap permeation
b) Light transmission- this test is to determine the effect of light passing through the bottle wall on the product stability and appearance. The bottle wall thickness can have a significant effect on the results obtained.
c) Product stability- it is unlikely that a compatibility problem, particularly with the film coated tablet, will occur, although it is necessary to check up full life of the product. There is possibility that either the smell or taste of tablets will be affected.
Every detail concerning a component specification must be communicated to and agreed upon with the manufacture, including packaging, transportation, and labeling requirements. If any of the details are missing confusion or mistakes may occur.
The main specifications requirements are the component drawing, artwork (printed components only) and the quality control testing and standards.
Quality control testing and standards- There are two classes of components:-
1. Primary – in contact with the product, e.g., ampules, vials, plastic bottles, polymer coated foils
2. Secondary – not in contact with the product, e.g., cartons, labels, leaflets
The critical parameters are for setting standard are:-
3. Compatibility and costumer usability
4. Chemical testing
Appearance – This can split into three categories:
(1) Critical – unacceptable at any level, e.g., rogue printed items in a delivery, incorrect printing of data such as the product name or concentration, insects in the bottle etc.
(2) Major- acceptable at a low level, the standard is decided by the pharmaceutical company. Examples of major appearance defects are missing print, making read text difficult, flashing on molded components and other defects.
(3) Minor- acceptable at a higher level than the major appearance defects. These will detract from perfection and include marked components, slight colour variations, slight smudging etc.
Dimensions – The dimensions of a component can be separated into two types:
1. Critical – requiring close control to ensure that the component functions correctly and can be used satisfactorily by packaging equipment.
2. Noncritical – necessary to maintain the component shape but not requiring close control for satisfactory function of the component.
The critical dimensions for each of these components are as follows:-
1. Vial – flange depth , flange diameter , bore diameter , vial height , body diameter , wall thickness, base thickness , concentricity and verticality
2. Rubber plug - flange depth, flange diameter and plug diameter
3. Aluminum overseal- internal skirt depth, external diameter, and aluminum thickness.
Compatibility and costumer usability- This involves checking that each component forming a pack fits together and functions correctly. Example – eye dropper pack
1. The nozzle must have a good interference fit into the bottle and allow one drop at a time deliver through the hole in the nozzle when inverted, but must not leak from the fitted position.
2. The cap must screw into position , and leakage must not occur when the bottle is squeezed into the inverted position, i.e., a sterile seal is maintained.
Chemical testing- The majority of chemical testing is required on primary components. The type of testing required depends on the type of component used.
1. Glass vials and Ampules – The USPXXII requirements for glass containers are chemical resistance and light transmission. The requirements vary from country to country, but basically testing determines whether the correct type of glass has been used for the manufacture and its suitability for use with pharmaceutical products.
2. Plastic primary components- the testing is more extensive with plastic components, requiring both biological and physicochemical tests. This is because plastic components contain other substances, such as plasticizers, stabilizers, antioxidants, pigments, lubricants and possibly residues from polymerization. Therefore, for components that are in direct with the product, this testing is required to ensure that the product is not affected during its life.
5. PHARMACEUTICAL PACKAGING
The quality control of components in pharmaceutical premises starts at the receiving stage. Once the component s are considered acceptable by the packaging material laboratory, the control of components quality must be maintained through each stage of handling and use , that is from the component storage and preparation to the filling , packaging, and dispatch of the product.
The packaging operation can involve many complex operations, all of which require careful control if product quality and security are to be maintained. The packaging operation means either the filling and packaging of non sterile products or the packaging stage of filled sterile products.
A. Area standard
Depending on the type of product and packaging operation, the standard requirement of the packaging area will vary, although there are several basic standards required:-
1. Each packaging line should be in separate room.
2. There should be covered floors and ceilings for easy cleaning.
3. The packaging operators should wear non –fiber shedding overalls that have a tight fit around the neck and sleeves. There should be no external pockets above waist height.
4. The filling part of the packaging operation should be enclosed and supplied with filtered air.
5. Basic precautions prior to filling can be operated, such as blowing the container with filtered air immediately before filling. Washing of containers should not be necessary, provided that the correct production and operation standards are in use in the supplier premises .
B. Packaging instructions
1. Packaging specifications
The following details must be included in the specifications:
· The product name, strength, and reference code to be packaged.
· The pack size and number of product items to be included in each pack, that is, the number of tablets, ampules, vials, etc.
· A description and reference of each packaging item to be included in the pack.
· Special precautions to be taken during the operation. For example the packaging of a moisture sensitive tablet may need to be performed under low humidity conditions.
· Detail the in-process control system to be operated. This will vary depending on the complexity of the packaging operations.
2. Specific batch details
The line supervisor will need to know the batch numbers and expiry dates for each batch to be packaged. This is to ensure that the correct batches are packaged for a specific customer, with the correct expiry date printed on the packs.
3. Customer requirements
The customer order may be to package all the product in each of the batches allocated or in an exact number of packs. The quantities of components required for each batch to be packaged need to be stated. This quantity must include overages based on expected wastage due to line set up, breakdowns , and in-process checks.
C. Product quality and security
Once the packaging line is set up and the correct packaging instructions are available, product quality and security must be maintained throughout the packaging stage. It can be done in following ways:
1. Critical devices – a critical device is any device that unless it is working correctly, could affect product quality. Each device must be identified and calibrated or challenge on a regular basis to ensure that it is working within specified limits.
2. Bar coding – all the printed items (printed containers , labels , and cartons ) should be bar coded , with the code reader said to read each item immediately to including into the pack. With the ampules and vials , a ring coding system or a similar method should be used.
3. Miss printing and missing component detectors – if these detectors have been proven to work correctly, they can give additional assurance of a satisfactory pack on the market.
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