Drugs and the pharmaceutical sciences

Filter Manufacture Quality Assurance and Validation 361
No. Designation of
procedural step Remarks
1a
1b
2
3a
3b
3c
4
5
6a
7
Preliminary rough Preliminary step for rough welds; only for very coarse
polish (''fettling'') work; recommended follow-up step: 1b, with 60-grain
abrasive
Rough polish First step for thick sheets, hot-rolled sheets or smooth
welds
Final step for producing a matte, non-directional surface
structure
these will be adjusted to fulfill the defined criteria. A release criteria, external to the
manufacturer, but as critical is a site acceptance test (SAT) of this equipment. At that
point the equipment is check at the client’s site, under the environmental conditions of
the client.
From an end-user standpoint, the release criteria of the vendor have to meet the risk
assessment criteria set by the end-user (and more often the regulatory authorities).
Depending on the quality impact of a specific component or equipment supplied, the
release criteria on both sides, vendor and end-user, will differ in stringency. The quality
of supplied water for injection (if not produced within the facility) has a higher risk
attached to it than a condensate valve on a tank. Different risk or impact classifications
have to be defined for product and equipment supplies (Fig. 7). Some products have
a direct impact on the quality of the end product, some have only a minor influence, and
some have no influence but are used to check on a component with a quality influence.
For example, an integrity test system does not have a direct influence, but is used to check
the integrity, i.e., quality of a sterilizing grade filter, which has an influence on the
quality. Therefore the calibration of such test system is essential. The release and test
criteria for these products will differ and be defined in a way which will meet the
necessary quality purpose. It would make no sense to use similar evaluation conditions
for non-critical items. It would just raise costs and possible process delays. Therefore
these risk assessments have to be performed before release criteria are defined.
QUALIFICATION OF EQUIPMENT
Recommended abrasive Grit
Peripheral
speed
in m/min
Preferably grinding wheel with 24 / 36
hard rubber or plastic bond
1,200 - 1,800
if 36 is necessary,
follow up with 60
1,200 - 1,800
a) Grinding wheel with hard
rubber or plastic bond
b) Set-up wheel
c) Grinding belt, if the shape
of the piece permits
Finish grind Standard step for cold-rolled sheet or coil
a) Set-up or rubber wheel
b) Grinding belt, if the shape
of the piece permits
80 / 100
1,500 - 2,400
Precision grind The surface finish corresponds to that of roll material in
accordancewith ''Procedure o (IV)''
a) Set-up wheel
b) Grinding belt, if the shape
of the piece permits
120 / 150
1,500 - 2,400
Precision grind
Precision grind
Brushing
Polishing or
lapping
Polishing
Preparatory step in producing a normal polish following a) Set-up wheel
step 3a.
b) Grinding belt, if the shape
of the piece permits
Intermediate step in producing a normal polish following a) Polishing wheel
step 3b
b) Grinding belt, if the shape
of the piece permits
To produce a smooth, matte, silk luster. This step, Tampico
following one of the ''o(IV)'' procedures, produces a
surface finish that corresponds to the designation
''burnished.'' Brushing finer (e.g., high-gloss polished)
surfaces produces a very attractive effect. The surface
finish will depend on the brush speed and the abrasive
used
Final step for producing a normal polish follwing step 3c Polishing wheel
(Note: lapping leaves fine chatter marks)
a) Preparatory step for producing a high-gloss polished Polishing wheel
surface following step 3c
180
1,500 - 2,400
240 abrasive paste for 2,400 - 3,000
set-up wheel, or 240 Grinding belt:
grinding belt
approx. 1,500
Abrasive paste made of 600 - 1,500
pounce or quartz
powder. Other
abrasives may also be
used, depending on the
desired surface finish
Burnishing compound
for stainless steels in
stick or cake form
320 - 400 finish 2,400 - 3,000
polishing compound in
stick or cake form
b) Preparatory step for producing a high-gloss polished
coil
Polishing belt
Burnishing compound
for stainless steels in
stick or cake form
approx. 1,500
Blasting
various
Glass beads
Stainless steel grit
Nonferrous quartz sand
FIGURE 6 Table of different polishing methods and the end result.
Probably the most descriptive and most utilized guidance on qualification mechanisms is
the GAMP (Good Automated Manufacturing Practice) guidance published by the ISPE