Scope

this standard specifies the specifications, technical indicators and requirements, test methods, inspection rules, and criterion rule. This standard is applicable to edible empty capsules made of various raw materials and excipients.

Specification

The empty capsule is a cylindrical hard capsule with a cap and body section, and various locking structures.

Request

Sizes

capsules are divided into 00#, 0 #, 1 #, 2 #, 3 #, 4 #, 5 # and other special sizes according to their capacity. Conventional extended capsules are represented by el, such as 0# el. The special size can be in accordance with the manufacturer’s own rules. The table below shows specifications of capsules of different sizes.

Capsule size Length (mm) Single wall thickness (mm) External diameter (mm) Weight tolerance (mg)
Theoretical data limit deviation Theoretical data limit deviation
00# cap 11.50~11.90 ±0.40 0.090~0.120 ±0.020 8.45~8.65 ±9.0
body 20.00~20.40 0.090~0.120 8.10~8.30
0# cap 10.80~11.20 0.085~0.115 7.55~7.75 ±8.0
body 18.40~18.80 0.085~0.115 7.25~7.45
1# cap 9.60~10.00 0.085~0.115 6.85~7.05 ±7.0
body 16.40~16.80 0.080~0.110 6.55~6.75
2# cap 8.80~9.20 0.080~0.110 6.27~6.25 ±6.0
body 15.20~15.60 0.080~0.110 6.00~6.18
3# cap 7.90~8.30 0.080~0.105 5.74~5.92 ±7.0
body 13.40~13.80 0.080~0.105 5.48~5.66
4# cap 7.00~7.40 0.080~0.105 5.23~5.41 ±4.0
  12.00~12.40 0.075~0.100 4.95~5.13
5# cap 6.20~6.60 0.070~0.110 4.83~4.98 ±3.0
body 9.00~9.40 0.065~0.105 4.61~4.73

Note:

The center value of length and single wall thickness is allowed to be revised within the specified range, but the limit deviation must be within the specified range.
The above specifications are for reference only and cannot be used as the basis for acceptance. The specific indicators can be discussed by both the supplier and the buyer according to the filling requirements.

Appearance

the below table shows the description of the various defects of the capsule appearance. Among them, “A-type defect” refers to a defect that causes the capsule to lose the characteristics as a container, maybe with low loading capacity, or maybe capsules lead to serious shutdown of the filling machine, or delays in filling production; “B-type defect” refers to the defect that causes the filling operation problem. For example, the capsules cannot be separated, the capsules cannot turn over, or capsules cannot be locked properly; the " C-type defect" refers to a defect that does not affect the filling operation but affects the appearance of the capsule.

 

Defect Description
A-type holes Holes caused by various reasons
uncut / edge cut inside The edge trimming is still connected to the capsule cap or capsule body, or be left inside the capsules
crack / notch Cutting edge crack is larger than 2mm / notch is larger than 2mm
shorter capsule bodies The length of the capsule body is more than 1mm shorter than required
flattened shell Capsule caps or bodies are flattened or twisted
split When joining capsules together, capsule caps and bodies are split by each other
cutting Any part left after cutting the capsule caps or bodies
B-type crack / notch Cutting edge crack is larger than 1mm / notch is larger than 1mm
single section Separated capsule caps or bodies
longitudinal pleat The length of a single longitudinal pleat on the capsule is longer than 5 mm, depression or bulge larger than 1mm
locking Capsules are locked when pre-locking capsule caps and bodies
double caps An additional cap on the capsule body
top concave part The diameter of the top concave part of the capsules: 00#, 0#: larger than 5.0mm; 1#, 2#, 3#, 4#, 5#: larger than 4.0mm
thickness The single wall thickness of the thinnest part is smaller than 0.03mm
Shorter / longer capsule caps The length of the cap is more than 1mm shorter or longer than the required length
longer capsule bodies The length of the capsule body is more than 1mm longer than the required length
C-type crack / notch Cutting edge crack is smaller than 1mm / notch is smaller than 1mm
bubble On the capsule, there is a bubble of which the diameter is larger than 0.5 mm or three or more bubbles of diameter larger than 0.3 mm
longitudinal pleat The length of longitudinal pleat on the capsule is longer than3 mm
top concave part The diameter of the top concave part of the capsules: 00#, 0#: larger than 3.0mm; 1#, 2#, 3#, 4#, 5#: larger than 2.0mm
heterochromatic point Black dots or colored points with a diameter larger than 0.3mm
scratch There is a scratch with a length of more than 2 mm on the outer surface
winkle The winkle on the capsule wall is larger than (5 × 3) mm
shred Cutting edge is with shred: 00# 0#, 1#: larger than 3mm, 2#, 3#, 4#, 5# larger than 2mm

Description of capsule printing defects: the following table shows a description of various defects of capsule printing. "Serious defects" refers to defects of which the printed patterns (including characters, letters) cannot be distinguished; "major defects" means defects of which the printed patterns can be distinguished but unclear or reversed; "minor defect" means that the printed patterns are clear the appearance but the appearance is affected.

Defect Description
serious defects Not printed There is no required pattern on the capsule
repeat printing Repeated printed pattern on the capsule
seriously incomplete The important strokes (important parts) of the pattern are incomplete, which may result in unidentifiable or incorrect identification
major defects

reverse

The direction of the pattern on the capsule caps and bodies is opposite to requirement
unclear The letters of the patterns are not clear, resulting in unclear pattern
position deviation More than a quarter of the pattern is covered by the cap after locking or the pattern on the cap is missing.
ink dot The diameter of the ink dot on the capsule is larger than 0.5mm
Ink mark The ink mark on the capsule is longer than or equal to 3mm
minor defect incomplete The text (letter) on the pattern is missing, and the pattern is identifiable (except for the missing printing of the locking part)
unclear The letters of the patterns are not clear, but the pattern is identifiable
position deviation Less than a quarter of the pattern is covered by the cap after locking or the pattern on the cap is missing.
ink dot The diameter of the ink dot on the capsule is about 0.3~ 0.5mm
Ink mark The ink mark on the capsule is longer than 1mm, and shorter than 3mm

Color

the color is uniform and shiny, and there is no obvious color difference among the productions of the same batch.

Inspection methods

Specification

Measure the length of the capsule cap and body using a length measuring tool with an accuracy of 0.01 mm.

Measure the single wall thickness of the capsule cap (1 mm from the trim) and body (inside the lock ring 1 mm) using a measuring tool with an accuracy of 0.01 mm.

Measure the external diameter of the capsule caps and bodies with a standard orifice plate with an accuracy of 0.01 mm or other effective method. It is not recommended to use a micrometer or a vernier caliper.

Capsule weight tolerance

Take 20 capsules, weigh the total weight using an electronic balance with an accuracy of 0.1 mg, and then weigh each capsule separately. Calculate the average weight of the capsule, and compare the weight of each capsule to the average capsule weight, wherein the maximum positive difference and the minimum negative difference means capsule weight tolerance. The result of the calculation is expressed as one decimal place.

Appearance

Place the capsule on a frosted glass lamp table equipped with lighting fixtures, and check by a person with visual acuity of 1.0 or above (including corrected vision) at a distance of 30 cm (where the light intensity is recommended to be controlled at 600-900 Lux), or use other automated inspection equipment.

Inspection rule

Batch division

empty capsules adopting the same film-forming material formula, the same process conditions, the same production line, the same specification, and continuously produced products in the certain time interval are be concerned as the same batch. The production process of each batch of products are with traceability, quality uniformity and stability.

Sampling

inspection rules: after checking the outer packaging, according to the following table, take a certain quantity of samples from the products of one batch, for inspection.

Number of packages per batch Number of packages need to be sampled
2~15 2
16~50 3
51~150 5
151~500 8

Take out the same amount of sample from each package separately, and mix them up, the total amount should not be less than 4000 pcs.Then test samples according to the rules specified in the counting sampling test procedure.

Acceptance quality limit

specification, appearance, inspection level of capsule weight tolerance, and acceptance quality limit (AQL) shall comply with the following table.

Quality category test sample number< acceptance quality limit & number
AQL Ac Re
specification length 125 0.65 2 3
single wall thickness
capsule weight tolerance 20 compliance 2 3
appearance capsule appearance defect A-type defect 1250 0.04 1 2
B-type defect 0.15 5 6
C-type defect 1 21 22
capsule printing defects serious defect 0.04 1 2
major defect 0.65 14 15
minor defect 1 21 22
Ac-acceptance / pcs  Re- rejection / pcs