Free Shipping On All UK Orders
The UK pharmaceutical industry operates under some of the most stringent regulatory requirements of any manufacturing sector. Good Manufacturing Practice (GMP) — as regulated by the MHRA and aligned with EU GMP guidelines (EudraLex Volume 4) — demands rigorous control of manufacturing environments, including physical separation between production zones and contamination prevention.
GMP Requirements Affecting PVC Strip Curtains
EU GMP Chapter 3 (Premises and Equipment) sets requirements relevant to PVC curtain installations in pharmaceutical facilities:
- Surface cleanability — surfaces proximate to the manufacturing environment must be smooth, impervious, non-particle-shedding and cleanable to the required classification standards
- Non-shedding materials — equipment materials must not shed particles, fibres or chemical residues into the manufacturing environment
- Zone separation — classified manufacturing zones (Grade A/B/C/D under EU GMP Annex 1) must be physically separated with integrity maintained
- Documented maintenance — all equipment, including PVC curtains used as zone boundaries, must be included in a documented maintenance programme
Appropriate PVC Grades for Pharmaceutical Use
Standard Grade (Grade D and Non-Classified Areas)
For relatively low-specification areas, standard clear PVC may be acceptable subject to GMP risk assessment. Key requirements: in good condition (no cracks or degradation), cleanable with cleaning agents used on site (typically IPA or similar sanitisers), and included in the maintenance programme with documented inspection records.
Anti-Static PVC (ESD-Sensitive Areas)
In areas adjacent to sensitive active pharmaceutical ingredients (APIs) or electronic processing equipment, anti-static PVC with surface resistivity in the dissipative range (10⁶–10⁹ Ω) is required to prevent electrostatic charge build-up.
Anti-Microbial PVC
For areas where microbial contamination is a specific concern, anti-microbial PVC incorporating silver ion biocidal agents provides an additional layer of protection. Note: anti-microbial PVC supplements, not replaces, cleaning and sanitisation requirements.
Documentation Requirements for GMP Compliance
- Material specification — supplier declaration of PVC compound composition, confirming no restricted substances at harmful concentrations
- Installation qualification (IQ) — documentation that the curtain was installed correctly
- Standard Operating Procedure (SOP) for cleaning, inspection and replacement
- Maintenance log — dated records of each inspection, cleaning event and strip replacement
- Change control — documentation when curtain strips or rail systems are changed
We can supply material specification documentation and technical data sheets suitable for inclusion in GMP qualification files.
Solvent Resistance
Many pharmaceutical manufacturing processes use organic solvents — IPA, acetone, ethanol, ethyl acetate — that can attack standard PVC formulations. If curtains will be exposed to solvent vapours or direct contact, specify a grade whose chemical resistance has been confirmed for the specific solvents used on site. Contact our technical team with the specific solvents involved for appropriate material selection advice.
Browse our pharmaceutical and cleanroom PVC strip curtains. GMP documentation available. Free UK delivery. Contact us to discuss your site-specific requirements.